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Recruiting NCT05561127

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

Phase III Interventional Bowel; Stricture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GIE Medical ProTractX3 TTS DCB, Control.
Who it may be relevant to
Registry conditions: Bowel; Stricture. Basic parameters: from 22 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • Combination product GIE Medical ProTractX3 TTS DCB
    The ProTractX3 Drug-coated balloon is a 0.035" guidewire compatible over-the-wire catheter.
  • Other Control
    Standard of Care Endoscopic Dilation

Primary outcome measures

  • Freedom from Stricture Recurrence [Time frame: 6 Months Post-Treatment]
  • Primary Safety Outcome [Time frame: 30 Days Post-Treatment]
Secondary outcome measures (2)
  • Freedom from clinically driven target stricture reintervention [Time frame: 6 Months Post-Procedure]
  • Improvement in GIQLI-10 score [Time frame: 6 Months Post-Procedure]

Eligibility criteria

Inclusion criteria

  • Age ≥ 22
  • Diagnosis of symptomatic benign bowel stricture with at least 2 previous dilations.
  • Willing and able to complete protocol required follow up
  • Willing and able to provide written informed consent
  • Stricture length ≤ 5 cm

Exclusion criteria

  • Female subjects who are pregnant or breastfeeding or plan to get pregnant in next 12 months
  • Contraindication to endoscopy, anesthesia, or deep sedation.
  • 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.
  • Benign stricture due to extrinsic compression
  • Stricture is not amenable to standard balloon dilation (e.g. severe angulation, unable to pass guidewire, etc.)
  • Stricture complicated with abscess, fistula, perforation, leakage or varices
  • 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
  • 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.
  • Received steroid injections into target stricture in the last 8 weeks
  • Stricture is not able to be dilated to ≥15mm in small bowel or ≥18mm in large bowel
  • 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)
  • Suspected perforation of gastrointestinal tract
  • Active systemic infection
  • Allergy to paclitaxel
  • Severe coagulation disorders or current use of anticoagulant or antiplatelet medication that cannot be safely managed per relevant societal guidelines
  • 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
  • Condition requiring treatment in urgent setting
  • Life expectancy of less than 24 months
  • 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.
  • Current participation in another pre-market drug or medical device clinical study unless in long term follow-up

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 33 centers
  • Honor Health — Scottsdale
  • University of California, Irvine — Irvine
  • Gastro Care Institute — Lancaster
  • Cedars Sinai — Los Angeles
  • San Diego Gastroenterology — San Diego
  • University of Colorado Anschutz — Aurora
  • University of Florida — Gainesville
  • Borland-Groover — Jacksonville
  • … and 25 more centers

Identifiers

NCT: NCT05561127 · PR2053

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗