xMedica

NCT05561127ClinicalTrials.gov

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

En recrutementAccepte des participants actuellement, selon la fiche du registre.
Contacter cette étude

En bref

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

Phase 3171 participants recherchés33 sites1 pays

Catégories

Gastro-entérologie et hépatologie45%Neurologie27%Ophtalmologie27%

Enregistré dans 1 registre

Une même étude peut être enregistrée dans plusieurs registres. Nous l'affichons une seule fois et renvoyons vers chaque fiche que nous détenons.

Les informations de l'essai sont affichées telles que publiées par le registre, dans leur langue d'origine.

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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.

Résumé

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

Affections

  • Bowel; Stricture

Éligibilité

SexeTous
Âges22 Years – Aucun maximum
Volontaires sainsNon

Éligibilité telle qu'elle figure dans le registre

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

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Type d'étudeInterventionnelle
PhasePhase 3
RépartitionRandomisée
Modèle d'interventionPARALLEL
Objectif principalTREATMENT
InsuSINGLE (1)
Recrutement171 participants recherchés

Promoteur et collaborateurs

  • GIE Medical Promoteur

Groupes et interventions

  • 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.

Interventions

  • Autre Control

    Standard of Care Endoscopic Dilation

  • Produit combiné GIE Medical ProTractX3 TTS DCB

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

Critères de jugement

  1. Critère de jugement principal

    Freedom from Stricture Recurrence

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

    Délai 6 Months Post-Treatment

  2. Critère de jugement 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)

    Délai 30 Days Post-Treatment

  3. Critère de jugement secondaire

    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.

    Délai 6 Months Post-Procedure

  4. Critère de jugement secondaire

    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.

    Délai 6 Months Post-Procedure

  5. Autre critère de jugement

    Surgery Free Survival

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

  6. Autre critère de jugement

    Improvement in GIQLI-10

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

  7. Autre critère de jugement

    Technical Success

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

  8. Autre critère de jugement

    Improvement in EOS

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

  9. Autre critère de jugement

    Dilations per year before and after treatment

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

  10. Autre critère de jugement

    Time between dilations

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

  11. Autre critère de jugement

    Estimated stricture diameter

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

Dates

Date de début1 novembre 2023 (réelle)
Achèvement principal1 décembre 2027 (estimée)
Achèvement1 juin 2032 (estimée)
Première publication30 septembre 2022 (réelle)
Dernière mise à jour25 juin 2025
Résultats publiésNon précisé dans la fiche du registre
Statut vérifié pour la dernière foisjuin 2025

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

32 sites sont en recrutement

United States

ÉtablissementVilleÉtat ou régionStatut
University of Colorado AnschutzAuroraColoradoEn recrutement
Brigham and Women's HospitalBostonMassachusettsEn recrutement
University of North CarolinaChapel HillNorth CarolinaEn recrutement
Rush UniversityChicagoIllinoisEn recrutement
University of FloridaGainesvilleFloridaEn recrutement
Baylor St. Luke's Medical CenterHoustonTexasEn recrutement
University of California, IrvineIrvineCaliforniaEn recrutement
Borland-GrooverJacksonvilleFloridaEn recrutement
Gastro Care InstituteLancasterCaliforniaEn recrutement
Cedars SinaiLos AngelesCaliforniaEn recrutement
University of LouisvilleLouisvilleKentuckyEn recrutement
Gastroenterology Associates of Central Georgia, LLCMaconGeorgiaEn recrutement
Tandem Clinical ResearchMarreroLouisianaEn recrutement
Research Associates of South FloridaMiamiFloridaEn recrutement
West Virginia UniversityMorgantownWest VirginiaEn recrutement
Vanderbilt University Medical CenterNashvilleTennesseeEn recrutement
Lenox Hill HospitalNew YorkNew YorkEn recrutement
New York Presbyterian Hospital- Columbia University Medical CenterNew YorkNew YorkEn recrutement
Hillcrest Medical ResearchOrange CityFloridaPas encore en recrutement
Orlando HealthOrlandoFloridaEn recrutement
Orlando HealthOrlandoFloridaEn recrutement
University of PennsylvaniaPhiladelphiaPennsylvaniaEn recrutement
Einstein Medical CenterPhiladelphiaPennsylvaniaEn recrutement
Thomas Jefferson UniversityPhiladelphiaPennsylvaniaEn recrutement
Rutgers UniversityPiscatawayNew JerseyEn recrutement
Allegheny Health NetworkPittsburghPennsylvaniaEn recrutement
The University of UtahSalt Lake CityUtahEn recrutement
San Diego GastroenterologySan DiegoCaliforniaEn recrutement
Honor HealthScottsdaleArizonaEn recrutement
Virginia MasonSeattleWashingtonEn recrutement
Swedish Medical CenterSeattleWashingtonEn recrutement
Washington UniversitySt LouisMissouriEn recrutement
Kansas Gastroenterology, LLCWichitaKansasEn recrutement

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

Aucun changement n'a été enregistré depuis que nous avons intégré cette fiche pour la première fois.

Un changement est enregistré chaque fois que le promoteur met à jour la fiche du registre. Le statut, les dates, le recrutement et les sites apparaissent ici au fur et à mesure de leur évolution.

Registre: ClinicalTrials.gov · NCT########

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