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Procedure

ESD-TORe vs APC-TORe for Obesity After Gastric Bypass (CREATORe Trial)

N/A
Recruiting
Led By C. Roberto Simons-Linares, MD
Research Sponsored by Carlos Roberto Simons-Linares
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients undergoing standard of care for treatment of obesity with endoscopic revisional procedure (a.k.a. TORe) who are enrolled in the GI Bariatric Endoscopy program and clinic at the study site
Adult patients with history of Roux-en-Y gastric bypass and weight regain
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year from date of procedure
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at two ways to do the TORe procedure to help people who've had weight regain after gastric bypass regain weight. It will compare which is safer and more successful.

Who is the study for?
This trial is for adults who had Roux-en-Y gastric bypass surgery but gained weight back. They must have a widened gastrojejunal connection seen on endoscopy and be getting standard obesity care at the study's GI Bariatric Endoscopy program.
What is being tested?
The trial compares two ways of doing the TORe procedure to see which one leads to more weight loss and is safer. Participants will randomly receive either c-TORe or E-TORe, with all other aspects of care being identical.
What are the potential side effects?
While specific side effects are not listed, procedures like TORe may cause sore throat, nausea, abdominal pain, bleeding, infection risk increase or complications related to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am receiving TORe for obesity as part of the GI Bariatric Endoscopy program.
Select...
I had Roux-en-Y gastric bypass surgery and have regained weight.
Select...
My stomach connection to the small intestine is enlarged.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year from date of procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year from date of procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Weight change at 12 months
Weight change at 6 months
Secondary study objectives
5% total body weight loss
Adverse event rate
Procedure time
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: E-TOReExperimental Treatment1 Intervention
Participants in this arm received the E-TORe procedure
Group II: c-TOReActive Control1 Intervention
Participants in this arm received the "classical" or c-TORe procedure

Find a Location

Who is running the clinical trial?

Carlos Roberto Simons-LinaresLead Sponsor
1 Previous Clinical Trials
122 Total Patients Enrolled
C. Roberto Simons-Linares, MDPrincipal InvestigatorThe Cleveland Clinic
1 Previous Clinical Trials
122 Total Patients Enrolled
~12 spots leftby Apr 2025
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