NCT05561127 · GIE Medical
Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Bowel
(PATENT-B)
What this study is about
To determine the safety and effectiveness of GIE Medical's ProTractX3™ TTS DCB for the treatment of recurrent benign bowel strictures.
View original scientific description
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
Endoscopic Obstruction Scale (EOS) of \> 1 when using a pediatric colonoscope or equivalent
Primary Safety Outcome
Time frame: 30 Days Post-Treatment
Incidence of device- and/or procedure-related Major Adverse Events (MAEs) (Death, perforation of the esophagus, bleeding requiring intervention or transfusion)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- 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 act
Where
- Scottsdale, Arizona
- Irvine, California
- Lancaster, California
- Los Angeles, California
- San Diego, California
- Aurora, Colorado
- Gainesville, Florida
- Jacksonville, Florida
- Miami, Florida
- Orange City, Florida
- Orlando, Florida
- Macon, Georgia
And 16 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 25, 2025 · Source of record for eligibility and locations