Bowel; Stricture
Conditions
Keywords
dcb, bowel stricture, drug coated balloon, paclitaxel coated balloon
Brief summary
To determine the safety and efficacy of GIE Medical's ProTractX3™ TTS DCB for the treatment of recurrent benign bowel strictures.
Interventions
COMBINATION_PRODUCTGIE Medical ProTractX3 TTS DCB
The ProTractX3 Drug-coated balloon is a 0.035 guidewire compatible over-the-wire catheter.
OTHERControl
Standard of Care Endoscopic Dilation
Sponsors
GIE Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from Stricture Recurrence | 6 Months Post-Treatment | Endoscopic Obstruction Scale (EOS) of \> 1 when using a pediatric colonoscope or equivalent |
| Primary Safety Outcome | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from clinically driven target stricture reintervention | 6 Months Post-Procedure | Freedom from clinically driven reintervention represents freedom from repeat dilation, incision, or surgical management of the target stricture for recurrent obstructive symptoms. |
| Improvement in GIQLI-10 score | 6 Months Post-Procedure | 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. |
Other
| Measure | Time frame |
|---|---|
| Dilations per year before and after treatment | 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years |
| Surgery Free Survival | 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years |
| Estimated stricture diameter | 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years |
| Time between dilations | 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years |
| Improvement in GIQLI-10 | 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years |
| Technical Success | 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years |
| Improvement in EOS | 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years |
Countries
United States
Contacts
Primary ContactErika Wang
Outcome results
None listed