Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Bowel
ConditionBowel; Stricture
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age22+
SponsorGIE Medical
About this trial
To determine the safety and efficacy of GIE Medical's ProTractX3™ TTS DCB for the treatment of recurrent benign bowel strictures.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
GIE Medical ProTractX3 TTS DCB
Combination productThe ProTractX3 Drug-coated balloon is a 0.035" guidewire compatible over-the-wire catheter.
Control
Other interventionStandard of Care Endoscopic Dilation
Treatment groups
171 Participants
are divided into 2 treatment groupsGroup A: GIE Medical ProTractX3 TTS DCBExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Freedom from Stricture Recurrence
Endoscopic Obstruction Scale (EOS) of \> 1 when using a pediatric colonoscope or equivalent
Time frame
6 Months Post-Treatment2
Primary Safety Outcome
Incidence of device- and/or procedure-related Major Adverse Events (MAEs) (Death, perforation of the esophagus, bleeding requiring intervention or transfusion)
Time frame
30 Days Post-TreatmentSecondary outcomes
1
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.
Time frame
6 Months Post-Procedure2
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.
Time frame
6 Months Post-ProcedureOther outcomes
1
Surgery Free Survival
Time frame
30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years2
Improvement in GIQLI-10
Time frame
30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years3
Technical Success
Time frame
30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years4
Improvement in EOS
Time frame
30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 yearsSponsors and contacts
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Source ClinicalTrials.gov