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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

CREATORe Trial 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.Check my eligibility

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.See study design

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.

CREATORe Trial 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.

CREATORe Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year from date of procedure

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

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

Primary outcome measures

Weight change at 12 months

Weight change at 6 months

Secondary outcome measures

5% total body weight loss

Adverse event rate

Procedure time

+1 more

CREATORe 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

0 / 3Eligibility criteria met

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

Frequently Asked Questions

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

Are there opportunities for enrolment into this clinical research?

"Affirmative, the official clinicaltrials.gov page shows that this research is now looking for participants. The investigation was initially posted on October 2nd 2023 and has been recently updated on November 9th 2023. 70 people from a single facility are needed to participate in the trial."

Answered by AI

What is the main aim of this experiment?

"The primary end-point of this research, monitored over a 6 month period from the date of medical intervention, is weight loss at 12 months. Additional evaluation criteria include adverse event rate, 5% total bodyweight reduction and mean procedure time."

Answered by AI

What is the current enrollment number for this research study?

"Affirmative. Information on clinicaltrials.gov declares that this experiment is actively recruiting participants, beginning from October 2nd 2023 and last edited on November 9th of the same year. At present, 70 volunteers are being recruited at a single medical centre."

Answered by AI