Comparing Reduction With ESD- Versus APC-TORe

Study acronym: CREATORe
StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 11 months later Apr 2027 → Apr 2028
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Record History

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  1. Primary completion pushed from Apr 2027 to Apr 2028 Show 5 more changesShow less
    • Enrollment reopened
    • Study completion pushed from Apr 2027 to Apr 2029
    • Eligibility criteria expanded, about 17 words
    • Site details revised
    • Publications: details revised at 16 of 16 entries
  2. Primary and study completion dates: Apr 2026 to Apr 2027
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v5
  3. Lead sponsor: Carlos Roberto Simons-Linares to Stephen Firkins
    • Site contact updated
    v4
  4. Primary and study completion dates: Apr 2025 to Apr 2026v3
  5. Primary endpoints revised (2)
    • Site contact updated
    v2
  6. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Stephen Firkins
2 trials monitored
See 1 trial at risk
Obesity
3,903 trials monitored
See 160 trials at risk
The goal of this clinical trial is to compare two variations of the same procedure used to assist with weight loss in patients who have a history of Roux-en-Y gastric bypass who have experienced weight regain. The procedure being studied is called the Transoral Outlet Reduction (TORe), and the trial will compare two different ways to complete the TORe procedure. The main question\[s\] it aims to answer are: * Which variation of the TORe procedure results in more weight loss? * Which variation of the TORe is safer? Participants who are eligible and willing to undergo the TORe procedure to assist with weight loss will have the procedure completed either one of the two ways. All other care will be exactly the same between the two groups. Researchers will compare outcomes between the two procedure variations, looking at which one results in more weight loss, is more successful, and safer.
Trial Details
NCT Number NCT06131281
Lead Sponsor Stephen Firkins
Conditions
(from sponsor)		 Obesity, Roux-en-y Anastomosis Site, Weight Gain
Related terms Obesity, Weight Gain
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov