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NCT05561127ClinicalTrials.gov

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

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En resumen

To determine the safety and efficacy of GIE Medical's ProTractX3™ TTS DCB for the treatment of recurrent benign bowel strictures.

Fase 3171 participantes buscados33 centros1 país

Categorías

Gastroenterología y hepatología45%Neurología27%Oftalmología27%

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 2023-11-01
  • 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 type7/10

    Clinical-event endpoint

  • Multi-centre8/8

    Multi-centre: 33 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: 171 participants (target), run at 33 sites.

How this score is built
  • Enrolment21/40

    171 participants (target)

  • Site count18/25

    33 sites

  • Country count0/15

    Single country

  • Planned duration10/10

    Planned over about 105 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 determine the safety and efficacy of GIE Medical's ProTractX3™ TTS DCB for the treatment of recurrent benign bowel strictures.

Afecciones

  • Bowel; Stricture

Elegibilidad

SexoTodos
Edades22 Years – Sin máximo
Voluntarios sanosNo

Elegibilidad tal como figura en el registro

Inclusion Criteria: 1. Age ≥ 22 2. Diagnosis of symptomatic benign bowel stricture with at least 2 previous dilations. 3. Willing and able to complete protocol required follow up 4. Willing and able to provide written informed consent 5. Stricture length ≤ 5 cm Exclusion Criteria: 1. Female subjects who are pregnant or breastfeeding or plan to get pregnant in next 12 months 2. Contraindication to endoscopy, anesthesia, or deep sedation. 3. Suspicion of malignant bowel stricture NOTE: Biopsy should be taken for every stricture during the initial endoscopy, however endoscopic balloon dilation may proceed without awaiting results if suspicion for malignancy is low in the opinion of the investigator. 4. Benign stricture due to extrinsic compression 5. Stricture is not amenable to standard balloon dilation (e.g. severe angulation, unable to pass guidewire, etc.) 6. Stricture complicated with abscess, fistula, perforation, leakage or varices 7. Stricture segment has moderate to severe active inflammation at the time of treatment. Moderate to severe inflammation is defined as any one of; ulcers \>0.5cm in diameter, ulcerated surface \>10%, affected (inflamed) surface \>50%, marked erythema, absent vascular pattern, significant friability, or erosions 8. Multiple clinically significant strictures unable to be treated with a single balloon (i.e. total segment length must be ≤5cm) NOTE: Clinically significant strictures include those that are unable to be passed by the endoscope. 9. Received steroid injections into target stricture in the last 8 weeks 10. Stricture is not able to be dilated to ≥15mm in small bowel or ≥18mm in large bowel 11. Diagnosis of metastatic cancer of any type that is not considered in remission or non-metastatic cancer that may require radiation treatment in the pelvic region (e.g. prostate cancer) 12. Suspected perforation of gastrointestinal tract 13. Active systemic infection 14. Allergy to paclitaxel 15. Severe coagulation disorders or current use of anticoagulant or antiplatelet medication that cannot be safely managed per relevant societal guidelines 16. Chronic systemic steroid use (defined as greater than 10 mg/day) for any medical conditions unless subject is willing to undergo a 4-week washout and discontinue steroid use 17. Condition requiring treatment in urgent setting 18. Life expectancy of less than 24 months 19. 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, etc. 20. Current participation in another pre-market drug or medical device clinical study unless in long term follow-up

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)
Inscripción171 participantes buscados

Patrocinador y colaboradores

  • GIE Medical Patrocinador

Grupos e intervenciones

  • GIE Medical ProTractX3 TTS DCBEXPERIMENTAL

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

  • ControlACTIVE_COMPARATOR

    Standard of Care.

Intervenciones

  • Otro Control

    Standard of Care Endoscopic Dilation

  • Producto de combinación GIE Medical ProTractX3 TTS DCB

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

Variables de resultado

  1. Variable de resultado principal

    Freedom from Stricture Recurrence

    Endoscopic Obstruction Scale (EOS) of \> 1 when using a pediatric colonoscope or equivalent

    Plazo 6 Months Post-Treatment

  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

    Freedom from clinically driven target stricture reintervention

    Freedom from clinically driven reintervention represents freedom from repeat dilation, incision, or surgical management of the target stricture for recurrent obstructive symptoms.

    Plazo 6 Months Post-Procedure

  4. Variable de resultado secundaria

    Improvement in GIQLI-10 score

    The Gastrointestinal Quality of Life Index (GIQLI) is a validated questionnaire developed as a health-related quality of life assessment tool for patients with gastrointestinal diseases. The items on the GIQLI-10 align closely with common obstructive symptoms found in patients with bowel strictures.

    Plazo 6 Months Post-Procedure

  5. Otra variable de resultado

    Surgery Free Survival

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

  6. Otra variable de resultado

    Improvement in GIQLI-10

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

  7. Otra variable de resultado

    Technical Success

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

  8. Otra variable de resultado

    Improvement in EOS

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

  9. Otra variable de resultado

    Dilations per year before and after treatment

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

  10. Otra variable de resultado

    Time between dilations

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

  11. Otra variable de resultado

    Estimated stricture diameter

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

Fechas

Fecha de inicio1 de noviembre de 2023 (real)
Finalización principal1 de diciembre de 2027 (estimada)
Finalización1 de junio de 2032 (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

32 centros están en reclutamiento

United States

CentroCiudadEstado o regiónEstado
University of Colorado AnschutzAuroraColoradoEn reclutamiento
Brigham and Women's HospitalBostonMassachusettsEn reclutamiento
University of North CarolinaChapel 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
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
Lenox Hill HospitalNew YorkNew YorkEn reclutamiento
New York Presbyterian Hospital- Columbia University Medical CenterNew YorkNew YorkEn reclutamiento
Hillcrest Medical ResearchOrange CityFloridaAún no recluta
Orlando HealthOrlandoFloridaEn reclutamiento
Orlando HealthOrlandoFloridaEn reclutamiento
University of PennsylvaniaPhiladelphiaPennsylvaniaEn reclutamiento
Einstein Medical CenterPhiladelphiaPennsylvaniaEn reclutamiento
Thomas Jefferson UniversityPhiladelphiaPennsylvaniaEn reclutamiento
Rutgers UniversityPiscatawayNew JerseyEn reclutamiento
Allegheny Health NetworkPittsburghPennsylvaniaEn reclutamiento
The University of UtahSalt Lake CityUtahEn reclutamiento
San Diego GastroenterologySan DiegoCaliforniaEn reclutamiento
Honor HealthScottsdaleArizonaEn reclutamiento
Virginia MasonSeattleWashingtonEn 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/NCT05561127