xMedica

NCT05561127ClinicalTrials.gov

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

In reclutamentoAccetta partecipanti ora, secondo la scheda del registro.
Contatta questo studio

In breve

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

Fase 3171 partecipanti ricercati33 centri1 paese

Categorie

Gastroenterologia ed epatologia45%Neurologia27%Oftalmologia27%

Registrato in 1 registro

Uno studio può essere registrato in più registri. Lo mostriamo una volta sola e colleghiamo ogni scheda in nostro possesso.

Le informazioni sulla sperimentazione sono mostrate così come pubblicate dal registro, nella lingua originale.

Ti interessa questo studio?

Accedi oppure crea un account per registrare il tuo interesse e seguire questo studio.

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.

Sintesi

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

Patologie

  • Bowel; Stricture

Idoneità

SessoTutti
Età22 Years – Nessun massimo
Volontari saniNo

Idoneità come riportata nel 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

Idoneità in frasi semplici

I criteri di questa scheda non sono ancora stati suddivisi in affermazioni distinte. Il testo del registro qui sopra è completo ed è la versione autorevole.

Disegno dello studio

Tipo di studioInterventistico
FaseFase 3
AssegnazioneRandomizzata
Modello di interventoPARALLEL
Finalità principaleTREATMENT
MascheramentoSINGLE (1)
Arruolamento171 partecipanti ricercati

Sponsor e collaboratori

  • GIE Medical Sponsor

Bracci e interventi

  • 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.

Interventi

  • Altro Control

    Standard of Care Endoscopic Dilation

  • Prodotto combinato GIE Medical ProTractX3 TTS DCB

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

Esiti misurati

  1. Esito primario

    Freedom from Stricture Recurrence

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

    Orizzonte temporale 6 Months Post-Treatment

  2. Esito primario

    Primary Safety Outcome

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

    Orizzonte temporale 30 Days Post-Treatment

  3. Esito secondario

    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.

    Orizzonte temporale 6 Months Post-Procedure

  4. Esito secondario

    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.

    Orizzonte temporale 6 Months Post-Procedure

  5. Altro esito

    Surgery Free Survival

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

  6. Altro esito

    Improvement in GIQLI-10

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

  7. Altro esito

    Technical Success

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

  8. Altro esito

    Improvement in EOS

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

  9. Altro esito

    Dilations per year before and after treatment

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

  10. Altro esito

    Time between dilations

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

  11. Altro esito

    Estimated stricture diameter

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

Date

Data di inizio1 novembre 2023 (effettiva)
Conclusione primaria1 dicembre 2027 (stimata)
Conclusione1 giugno 2032 (stimata)
Prima pubblicazione30 settembre 2022 (effettiva)
Ultimo aggiornamento25 giugno 2025
Risultati pubblicatiNon indicato nella scheda del registro
Stato verificato l'ultima voltagiugno 2025

«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.

Centri

32 centri stanno reclutando

United States

StrutturaCittàStato o regioneStato
University of Colorado AnschutzAuroraColoradoIn reclutamento
Brigham and Women's HospitalBostonMassachusettsIn reclutamento
University of North CarolinaChapel HillNorth CarolinaIn reclutamento
Rush UniversityChicagoIllinoisIn reclutamento
University of FloridaGainesvilleFloridaIn reclutamento
Baylor St. Luke's Medical CenterHoustonTexasIn reclutamento
University of California, IrvineIrvineCaliforniaIn reclutamento
Borland-GrooverJacksonvilleFloridaIn reclutamento
Gastro Care InstituteLancasterCaliforniaIn reclutamento
Cedars SinaiLos AngelesCaliforniaIn reclutamento
University of LouisvilleLouisvilleKentuckyIn reclutamento
Gastroenterology Associates of Central Georgia, LLCMaconGeorgiaIn reclutamento
Tandem Clinical ResearchMarreroLouisianaIn reclutamento
Research Associates of South FloridaMiamiFloridaIn reclutamento
West Virginia UniversityMorgantownWest VirginiaIn reclutamento
Vanderbilt University Medical CenterNashvilleTennesseeIn reclutamento
Lenox Hill HospitalNew YorkNew YorkIn reclutamento
New York Presbyterian Hospital- Columbia University Medical CenterNew YorkNew YorkIn reclutamento
Hillcrest Medical ResearchOrange CityFloridaNon ancora in reclutamento
Orlando HealthOrlandoFloridaIn reclutamento
Orlando HealthOrlandoFloridaIn reclutamento
University of PennsylvaniaPhiladelphiaPennsylvaniaIn reclutamento
Einstein Medical CenterPhiladelphiaPennsylvaniaIn reclutamento
Thomas Jefferson UniversityPhiladelphiaPennsylvaniaIn reclutamento
Rutgers UniversityPiscatawayNew JerseyIn reclutamento
Allegheny Health NetworkPittsburghPennsylvaniaIn reclutamento
The University of UtahSalt Lake CityUtahIn reclutamento
San Diego GastroenterologySan DiegoCaliforniaIn reclutamento
Honor HealthScottsdaleArizonaIn reclutamento
Virginia MasonSeattleWashingtonIn reclutamento
Swedish Medical CenterSeattleWashingtonIn reclutamento
Washington UniversitySt LouisMissouriIn reclutamento
Kansas Gastroenterology, LLCWichitaKansasIn reclutamento

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

Non è stata registrata alcuna modifica da quando abbiamo acquisito questa scheda.

Viene registrata una modifica ogni volta che lo sponsor aggiorna la scheda del registro. Stato, date, arruolamento e centri compaiono qui man mano che cambiano.

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

https://xmedica.io/trials/ctgov/NCT05561127