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Procedure

Endoscopic Treatment for Gastrointestinal Perforation

Phase 1

Waitlist Available

Research Sponsored by The Oregon Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ability to undergo general anesthesia

Gastrointestinal fistula and perforation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial is testing whether new endoscopic tools are safe and effective in the treatment of gastrointestinal leaks or perforations, which are currently treated through either open or laparoscopic surgical procedures.

Who is the study for?

This trial is for individuals who can undergo general anesthesia and give informed consent, with a gastrointestinal fistula or perforation. It's not suitable for those with a BMI of 40 or higher, altered gastric anatomy, severe abdominal inflammation or abscesses, contraindications to upper GI endoscopy or colonoscopy, or esophageal strictures.Check my eligibility

What is being tested?

The study is testing new endoscopic tools as an alternative to open or laparoscopic surgery in treating gastrointestinal leaks and perforations. The goal is to see if these less invasive methods are safe and effective.See study design

What are the potential side effects?

Potential side effects may include discomfort at the procedure site, bleeding, infection risk from the intervention, possible adverse reactions to anesthesia used during the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can safely be put under general anesthesia.

Select...

I have a gastrointestinal fistula or perforation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with adverse events as a measure of safety and tolerability

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Oregon ClinicLead Sponsor

13 Previous Clinical Trials

1,465 Total Patients Enrolled

Media Library

Endoscopic Treatment (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT01303653 — Phase 1

Gastrointestinal Fistula Research Study Groups:

Gastrointestinal Fistula Clinical Trial 2023: Endoscopic Treatment Highlights & Side Effects. Trial Name: NCT01303653 — Phase 1

Endoscopic Treatment (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01303653 — Phase 1

Frequently Asked Questions

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

How sound is this therapy for individuals?

"The safety of this medication is only supported by a small amount of evidence, so it was rated 1. This study has been classified as Phase 1 and thus provides limited knowledge about its efficacy."

Answered by AI

Is participation in this experiment limited to individuals younger than 85 years of age?

"Individuals aged between 18 and 85 are eligible to participate in this trial."

Answered by AI

To what extent do potential participants need to meet criteria in order to join this research project?

"To qualify for inclusion in this study, candidates must have intestinal fistula and be between 18 and 85 years of age. The trial aims to enrol 25 patients."

Answered by AI

Is this research project presently open to new participants?

"The details published on clinicaltrials.gov indicate that this research endeavour is not recruiting patients currently, with the most recent amendment to its listing occurring in February 2011. Nevertheless, there are presently 110 other trials welcoming participants while this one is inactive."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Endoscopic Treatment of Intestinal Fistulas and Perforations

2010. "Endoscopic Treatment of Intestinal Fistulas and Perforations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01303653.

All > Paid Studies Oregon