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Using a special balloon to treat recurring benign bowel strictures

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

Phase 3 Interventional GIE Medical · NCT05561127

This study is testing a special drug-coated balloon treatment for people with recurring bowel strictures to see if it works better than the usual methods they've already tried.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment171 (estimated)
Ages22 Years and up
SexAll
SponsorGIE Medical Industry-sponsored
Drugs / interventionsradiation
Locations33 sites (Scottsdale, Arizona and 32 other locations)
Trial IDNCT05561127 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of GIE Medical's ProTractX3™ TTS drug-coated balloon (DCB) for patients suffering from recurrent benign bowel strictures. Participants will receive the DCB intervention after having undergone at least two previous dilations for their condition. The study aims to determine if this innovative approach can improve patient outcomes compared to standard treatments. Follow-up assessments will be conducted to monitor the results and any potential complications.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 22 and older who have a diagnosis of symptomatic benign bowel stricture and have undergone at least two previous dilations.

Not a fit: Patients with malignant bowel strictures, those with contraindications to endoscopy, or those whose strictures are not amenable to standard balloon dilation may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective solution for patients with recurrent benign bowel strictures, potentially reducing the need for repeated procedures.

How similar studies have performed: Other studies using drug-coated balloons for similar conditions have shown promising results, indicating that this approach may be effective.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Scottsdale, Arizona and 32 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions BowelStricturedcbbowel stricturedrug coated balloonpaclitaxel coated balloon
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.