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Anti-mitotic Agent

Paclitaxel Coated Balloon for Bowel Stricture (PATENT-B Trial)

Phase 3
Recruiting
Research Sponsored by GIE Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post-procedure
Awards & highlights

PATENT-B Trial Summary

This trial tests a device to treat blocked bowels due to benign causes, to see if it is safe and effective.

Who is the study for?
Adults over 22 with benign bowel strictures that have been dilated twice before can join. They must be able to follow the study plan and give consent. Pregnant or breastfeeding women, those with paclitaxel allergies, or people on certain medications are excluded.Check my eligibility
What is being tested?
The trial is testing GIE Medical's ProTractX3 TTS DCB against a control for treating non-cancerous bowel narrowings. It aims to see if this treatment is safe and works well in keeping the bowels open.See study design
What are the potential side effects?
Possible side effects may include reactions related to the device or procedure such as pain, bleeding, infection at the site of treatment, allergic reaction to materials used in the balloon device, or complications from endoscopy.

PATENT-B Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Freedom from Stricture Recurrence
Primary Safety Outcome
Secondary outcome measures
Stenosis
Improvement in GIQLI-10 score
Other outcome measures
Dilations per year before and after treatment
Estimated stricture diameter
Improvement in EOS
+4 more

PATENT-B Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: GIE Medical ProTractX3 TTS DCBExperimental Treatment1 Intervention
The ProTractX3 Drug-coated balloon is a 0.035" guidewire compatible over-the-wire catheter.
Group II: ControlActive Control1 Intervention
Standard of Care.

Find a Location

Who is running the clinical trial?

GIE MedicalLead Sponsor
4 Previous Clinical Trials
225 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment currently recruiting participants?

"As per the clinicaltrials.gov website, this medical research is not seeking applicants at present. Originally posted on November 1st 2023 and last updated 9th May 2023, there are 216 other studies that currently require participants to join their trials."

Answered by AI

Is the GIE Medical ProTractX3 TTS DCB clinically proven to be secure for patients?

"The safety of GIE Medical ProTractX3 TTS DCB is rated highly, with a score of 3. This reflects the fact that there are multiple rounds of clinical data demonstrating efficacy and supporting its safety record."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Bowel
2023. "Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Bowel". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05561127.
~68 spots leftby Sep 2024
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