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NCT05561114ClinicalTrials.gov

Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Esophagus

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En resumen

To evaluate the safety and efficacy of the ProTractX3™ DCB for the treatment of benign esophageal strictures.

Fase 3198 participantes buscados34 centros1 país

Categorías

Gastroenterología y hepatología100%

Registrado en 1 registro

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La información del ensayo se muestra tal como la publicó el registro, en su idioma original.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Registered before enrolment beganFirst posted 2022-09-30; recorded start 2023-12-01
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are randomly assignedAllocation is recorded as randomised
  • Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Uses blinding (masking)A masking level is recorded in the record
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 3 other studies in this databaseCounted from the lead sponsor named in the record (GIE Medical)
  • No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database
  • The record lists 1 condition.
  • Lead sponsor type recorded as: industry.
  • Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourSTRONG

A strong methodological design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation20/20

    Participants are randomly allocated between arms

  • Blinding7/20

    Single-blind

  • Control arm15/15

    Active-comparator control arm

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type3/10

    Surrogate or intermediate endpoint (conservative default)

  • Multi-centre8/8

    Multi-centre: 34 sites

  • Data monitoring committee7/7

    A data monitoring committee is in place

  • Prospective registration5/5

    Registered before the study start date

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleSMALL

A small study: 198 participants (target), run at 34 sites.

How this score is built
  • Enrolment22/40

    198 participants (target)

  • Site count18/25

    34 sites

  • Country count0/15

    Single country

  • Planned duration10/10

    Planned over about 89 months

  • Sponsor scale2/10

    GIE Medical has led 4 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Resumen

To evaluate the safety and efficacy of the ProTractX3™ DCB for the treatment of benign esophageal strictures.

Afecciones

  • Esophageal Stricture

Elegibilidad

SexoTodos
Edades22 Years – Sin máximo
Voluntarios sanosNo

Elegibilidad tal como figura en el registro

Inclusion Criteria: 1. Age ≥ 22 years 2. Diagnosis of a benign esophageal stricture with at least 2 previous dilations 3. Ogilvie Dysphagia Score of ≥2 4. Minimum esophageal lumen diameter \<13 mm 5. Willing and able to complete protocol required follow-up visits 6. Willing and able to provide written informed consent 7. Strictures ≤5cm in total length 8. Target benign esophageal stricture etiologies include: 1. Peptic stricture, 2. Schatzki's ring, 3. Stricture due to prior infection, 4. Post-procedural (e.g. ESD/EMR/RFA/Cryo) stricture 5. Post surgical (e.g. anastomotic), including post curative esophagectomy with or without prior neoadjuvant chemoradiation therapy Exclusion Criteria: 1. Two or more clinically significant (e.g. non-traversable) strictures with total length \>5cm or unable to be treated with a single balloon. 2. Female subjects who are pregnant or breastfeeding or plan to become pregnant in next 12 months 3. Contraindication to endoscopy, anesthesia or deep sedation 4. Benign esophageal stricture due to extrinsic esophageal compression, caustic ingestion, lichen planus, and purely radiation induced strictures post head/neck cancer treatment. 5. History of diagnosis of eosinophilic esophagitis (EoE) 6. Signs or suspicion of a malignant esophageal stricture NOTE: If stricture is suspicious for malignancy based on clinical or endoscopic presentation, malignancy must be excluded by biopsy prior to enrollment. Subjects with a history of invasive esophageal cancer should have recurrence excluded by advanced imaging (e.g. CT/PET scan) and biopsy within 6 months of enrollment. 7. Diagnosis of metastatic cancer of any type that is not considered in remission or non-metastatic cancer that may require radiation treatment in the neck or thoracic region NOTE: A prior diagnosis of esophageal cancer is acceptable if considered in remission and recurrence has been excluded by advanced imaging and biopsy within 6 months of enrollment. 8. Suspected perforation of gastrointestinal tract 9. Inability to pass guidewire across stricture 10. Active systemic infection 11. Allergy to paclitaxel or structurally related compounds 12. Severe coagulation disorders or current use of anticoagulant or antiplatelet medication that cannot be safely managed per recommended guidelines prior to the index procedure 13. Chronic systemic steroid use for any medical conditions unless subject is willing to undergo a 4-week washout and discontinue steroid use 14. Received steroid injections into target stricture in the last 8 weeks. 15. Stricture not amenable to endoscopic dilation to ≥ 18 mm in the opinion of the investigator 16. Current use of nasal or oral feeding tube unless tube is removed prior to baseline assessments and subject maintains normal swallowing function. 17. Acute stricture condition that requires emergent procedure (e.g. immediate dilation) 18. Stricture complicated with abscess, fistula, deep ulceration, perforation, leakage or varices, or thrombosis, etc 19. Life expectancy of less than 24 months 20. Concurrent medical condition that would affect the investigator's ability to evaluate the patient's condition or could compromise patient safety, such as recent myocardial infarction, severe pulmonary disease, bleeding diathesis, large thoracic aneurysm, pharyngeal or cervical deformity, ongoing infection, etc 21. Current participation in another pre-market drug or medical device clinical study that has not reached it's primary endpoint. 22. Dysphagia related to primary motility disorders, such as achalasia, diffused esophageal spasm, ineffective esophageal motility (IEM), hypertensive lower esophageal sphincter, esophageal outlet obstruction, etc. 23. Active erosive esophagitis with a Los Angeles classification of Grade B-D at the time of endoscopy. 24. Significant esophageal dilation proximal to the stricture that, in the Investigator's opinion, may impact long-term esophageal motility. 25. Intolerant to effective acid suppression medication (e.g. proton pump inhibitors, H2 receptor antagonists) 26. Concurrent gastric and/or duodenal obstruction

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Tipo de estudioDe intervención
FaseFase 3
AsignaciónAleatorizado
Modelo de intervenciónPARALLEL
Propósito principalTREATMENT
EnmascaramientoSINGLE (1)
Inscripción198 participantes buscados

Patrocinador y colaboradores

  • GIE Medical Patrocinador

Grupos e intervenciones

  • ControlACTIVE_COMPARATOR

    Standard of Care Endoscopic Dilation

  • GIE Medical ProTractX3 TTS DCBEXPERIMENTAL

    The ProTractX3 Drug-coated balloon is a 0.035" guidewire compatible over-the-wire catheter.

Intervenciones

  • Otro Control

    Standard Endoscopic Dilation

  • Producto de combinación GIE Medical ProTractX3 TTS DCB

    Paclitaxel Coated Balloon

Variables de resultado

  1. Variable de resultado principal

    Treatment Success

    1\. The primary efficacy endpoint is freedom from stricture recurrence, measured as the time from Index procedure until stricture recurrence through 6 months post-procedure. Stricture recurrence is defined as an esophageal diameter \<13mm as measured using a functional luminal imaging probe, or clinically driven reintervention at the treated area within 6 months post-procedure as determined by the Clinical Events Committee

    Plazo 6 Months Post-Procedure

  2. Variable de resultado principal

    Primary Safety Outcome

    Incidence of device- and/or procedure-related Major Adverse Events (MAEs) (Death, perforation of the esophagus, bleeding requiring intervention or transfusion)

    Plazo 30 Days Post-Treatment

  3. Variable de resultado secundaria

    Annualized Rate of Reintervention

    The annualized reintervention rate is defined as the annualized number of clinically driven interventions and will be assessed by comparing the annualized rate per patient year between groups using a test of Poisson rates.

    Plazo Annually

  4. Variable de resultado secundaria

    Diameter Improvement at 6 months

    The minimum esophageal stricture diameter will be assessed by a functional luminal imaging probe (EndoFLIP) during endoscopy and compared between the Test and Control arms. The minimum esophageal stricture diameter will be measured at baseline and during the 6-month follow-up, or at the time of a reintervention if one occurs prior to 6 months.

    Plazo 6 Months Post-Procedure

  5. Variable de resultado secundaria

    Clinical Responder Rate at 6 months

    Plazo 6 Months Post-Procedure

  6. Variable de resultado secundaria

    Freedom from clinically driven target stricture reintervention through 6 months post-procedure

    Plazo 6 Months Post-Procedure

  7. Variable de resultado secundaria

    Freedom from symptom recurrence through 6 months post-procedure

    Plazo 6 Months Post-Procedure

  8. Otra variable de resultado

    Secondary Patency

    Plazo Time between the index procedure to the second clinically driven intervention

  9. Otra variable de resultado

    Technical Success

    Plazo Procedure

  10. Otra variable de resultado

    Annualized rate of dilations before and after treatment

    Plazo Annually

  11. Otra variable de resultado

    Improvement in time between dilations

    Plazo Between Dilations

  12. Otra variable de resultado

    Improvement in Ogilvie Dysphagia Score at each follow-up

    Plazo 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years

  13. Otra variable de resultado

    Improvement in Dysphagia Handicap Index score at each follow-up

    Plazo 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years

  14. Otra variable de resultado

    Stricture characteristics per functional imaging

    Plazo Between Dilations

  15. Otra variable de resultado

    Number of esophageal dilation procedures through each follow up

    Plazo 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years

  16. Otra variable de resultado

    Freedom from clinically driven reintervention through each follow-up

    Plazo 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years

  17. Otra variable de resultado

    Freedom from symptom recurrence through each follow-up

    Plazo 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years

  18. Otra variable de resultado

    VAS for pain scores through 30-day follow-up

    Plazo 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years

  19. Otra variable de resultado

    Composite EQ-5D quality of life scores at each follow-up

    Plazo 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years

Fechas

Fecha de inicio1 de diciembre de 2023 (real)
Finalización principal1 de octubre de 2026 (estimada)
Finalización1 de abril de 2031 (estimada)
Primera publicación30 de septiembre de 2022 (real)
Última actualización25 de junio de 2025
Resultados publicadosNo indicado en el registro
Estado verificado por última vezjunio de 2025

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

33 centros están en reclutamiento

United States

CentroCiudadEstado o regiónEstado
University of Colorado AnschutzAuroraColoradoEn reclutamiento
Birmingham Gastroenterology AssociatesBirminghamAlabamaAún no recluta
Brigham and Women's HospitalBostonMassachusettsEn reclutamiento
University of North Carolina Chapel HillChapel HillNorth CarolinaEn reclutamiento
Rush UniversityChicagoIllinoisEn reclutamiento
University of FloridaGainesvilleFloridaEn reclutamiento
Baylor St. Luke's Medical CenterHoustonTexasEn reclutamiento
University of California, IrvineIrvineCaliforniaEn reclutamiento
Borland-GrooverJacksonvilleFloridaEn reclutamiento
Gastro Care InstituteLancasterCaliforniaEn reclutamiento
Sierra Clinical ResearchLas VegasNevadaEn reclutamiento
Cedars SinaiLos AngelesCaliforniaEn reclutamiento
University of LouisvilleLouisvilleKentuckyEn reclutamiento
Gastroenterology Associates of Central Georgia, LLCMaconGeorgiaEn reclutamiento
Tandem Clinical ResearchMarreroLouisianaEn reclutamiento
Research Associates of South FloridaMiamiFloridaEn reclutamiento
West Virginia UniversityMorgantownWest VirginiaEn reclutamiento
Vanderbilt University Medical CenterNashvilleTennesseeEn reclutamiento
New York Presbyterian Hospital- Columbia University Medical CenterNew YorkNew YorkEn reclutamiento
Hillcrest Medical ResearchOrange CityFloridaEn reclutamiento
Orlando HealthOrlandoFloridaEn reclutamiento
University of PennsylvaniaPhiladelphiaPennsylvaniaEn reclutamiento
Thomas Jefferson UniversityPhiladelphiaPennsylvaniaEn reclutamiento
Einstein Medical CenterPhiladelphiaPennsylvaniaEn reclutamiento
Rutgers UniversityPiscatawayNew JerseyEn reclutamiento
Allegheny Health NetworkPittsburghPennsylvaniaEn reclutamiento
TEN20 Clinical ResearchPlanoTexasEn reclutamiento
Oregon Health and Science UniversityPortlandOregonEn reclutamiento
The University of UtahSalt Lake CityUtahEn reclutamiento
San Diego GastroenterologySan DiegoCaliforniaEn reclutamiento
Honor HealthScottsdaleArizonaEn reclutamiento
Swedish Medical CenterSeattleWashingtonEn reclutamiento
Washington UniversitySt LouisMissouriEn reclutamiento
Kansas Gastroenterology, LLCWichitaKansasEn reclutamiento

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

No se han registrado cambios desde que incorporamos este registro por primera vez.

Se registra un cambio cada vez que el patrocinador actualiza el registro. El estado, las fechas, la inscripción y los centros aparecen aquí a medida que cambian.

Registro: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT05561114