The RESET System Pivotal Clinical Trial (Protocol Revision K)

Study acronym: STEP-1
StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 2 years later across 2 updates Dec 1, 2025 → Dec 30, 2027
Primary endpoint added 1 → 2 primary endpoints
See other at-risk trials from Morphic Medical Inc.

Record History

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  1. Primary completion pushed from Mar 30, 2027 to Dec 30, 2027 Show 5 more changesShow less
    • Trial sites expanded: 12 → 27 locations
    • Study completion pushed from May 1, 2027 to Sep 30, 2029
    • Eligibility criteria expanded, about 42 words
    • Study description revised
    • Study title revised
  2. Primary completion pushed from Dec 1, 2025 to Mar 30, 2027 Show 8 more changesShow less
    • Primary endpoint(s) modified
    • Trial sites expanded: 7 → 12 locations
    • Study completion pushed from Dec 1, 2026 to May 1, 2027
    • Eligibility criteria expanded, about 42 words
    • Secondary endpoints: 16 to 7
    • Publications: details revised at 15 of 17 entries
    • Study description expanded, about 2 words
    • Study title expanded, about 3 words
  3. Primary completion date: Apr 1, 2024 to Dec 1, 2025v5 Show 8 more changesShow less
    • Enrollment target: 240 to 264
    • Study sites: 6 to 7
    • Study completion date: Apr 1, 2025 to Dec 1, 2026
    • Interventions: EndoBarrier Liner (Device), Sham (Other) to RESET Liner (Device), Sham (Other)
    • Eligibility criteria shortened, about 37 words
    • Secondary endpoints: 14 to 16
    • Study title revised
    • Study description shortened, about 2 words
  4. Study title expanded, about 1 wordv4
  5. Primary completion date: Apr 1, 2023 to Apr 1, 2024v3 Show 5 more changesShow less
    • Study sites: 5 to 6
    • Study completion date: Apr 1, 2024 to Apr 1, 2025
    • Eligibility criteria shortened, about 22 words
    • Secondary endpoints revised (14)
    • Study title revised
  6. Eligibility criteria expanded, about 63 words
    • Study description revised
    • Site contacts updated at 4 of 5 sites
    v2
  7. 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.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Morphic Medical Inc.
1 trial monitored
See 1 trial at risk
Diabetes
5,101 trials monitored
See 233 trials at risk
Obesity
3,888 trials monitored
See 157 trials at risk
Type 2 Diabetes
2,236 trials monitored
See 113 trials at risk
A Randomized, Multi-Center, Pivotal Efficacy and Safety Study Evaluating the RESET System for Glycemic Improvement in Patients with Inadequately Controlled Type 2 Diabetes and Obesity, the STEP-1 Study. A multi-center, double-blinded, randomized, sham-controlled trial to evaluate the safety and effectiveness of the RESET System plus moderate intensity lifestyle and dietary counseling compliant with 2024 ADA Standard of Care as compared to a sham control receiving moderate intensity lifestyle and dietary counseling. Both the treatment and sham group will practice medical management compliant with STEP-1 Study Guidelines. Patients will be randomized 3 (RESET):1 (Sham).
Trial Details
NCT Number NCT04101669
Lead Sponsor Morphic Medical Inc.
Collaborators: Biostatistical Consulting, Inc.
Conditions
(from sponsor)		 Diabetes type2, Obesity
Related terms Diabetes Mellitus, Type 2, Obesity
Enrollment 264 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov