RESET System Pivotal Trial (Rev F)

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Morphic Medical Inc.
Study ID
NCT04101669
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • RESET Liner — DEVICE
    The RESET System is provided as a single-use, sterile device and consists of an RESET Liner preloaded, packaged and sterilized within the RESET Delivery System. The RESET Delivery System is utilized to deliver the RESET Liner to the proximal small intestine. The RESET Liner is removed using the RESET Retrieval System. The RESET System incorporates no pharmacological, biological tissue or blood products.
  • Sham — OTHER
    Patient receives upper endoscopy but no treatment

Study Details

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).

Key Dates

Start date
Sep 9, 2019
Status verified
Jul 2024
Primary completion
Dec 1, 2025
Completion
Dec 1, 2026

Study Design

Enrollment
264 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: RESET
    Patients in ARM 1, will receive an upper endoscopy and will be treated with the RESET Liner
  • Sham Comparator: Sham
    Patients in Arm 2 will receive an upper endoscopy, but will not be treated with the RESET Liner.

Primary Outcome Measure

Change in HbA1c [ Time Frame: 9 Months ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
MedStar Health Research InstituteWashington D.C.District of Columbia20010
Kendra Green
[email protected]
202-877-5819
John Brebbia, MD
[email protected]
202-877-5819
John Brebbia, MD (PRINCIPAL_INVESTIGATOR)
Jean Park, MD (SUB_INVESTIGATOR)
Adline Ghazi, MD (SUB_INVESTIGATOR)
Nasrin Ansari, MD (SUB_INVESTIGATOR)
University of Miami HospitalMiamiFlorida33166
Eli J Monzon
[email protected]
Nestor De La Cruz, MD
[email protected]
Nestor De La Cruz, MD (PRINCIPAL_INVESTIGATOR)
Gianluca Iacobellis, MD (SUB_INVESTIGATOR)
Brigham and Women's HospitalBostonMassachusetts02115
Michele Ryan, MS
[email protected]
617-525-8266
Samantha Geltz
[email protected]
Christopher C Thompson, MD (PRINCIPAL_INVESTIGATOR)
Pichamol Jirapinyo, MD (SUB_INVESTIGATOR)
Marvin Ryou, MD (SUB_INVESTIGATOR)
Caroline Apovian, MD (SUB_INVESTIGATOR)
Michigan Medicine, Division of Gastroenterology and HepatologyAnn ArborMichigan48109
Carman Richison
[email protected]
734-615-6258
Sarah Volk
[email protected]
734-647-3082
Allison R Schulman, MD (PRINCIPAL_INVESTIGATOR)
Elif A Oral, MD (SUB_INVESTIGATOR)
Richard s Kwon, MD (SUB_INVESTIGATOR)
Andrew T Krafton, MD (SUB_INVESTIGATOR)
Weill Cornell MedicineNew YorkNew York10021
Dominique Gay
[email protected]
646-962-5370
Jessica Siguencia
[email protected]
Reem Sharaiha, MD (PRINCIPAL_INVESTIGATOR)
David Carr-Locke, MD (SUB_INVESTIGATOR)
Shrihari Mahadev, MD (SUB_INVESTIGATOR)
Kartik Sampath, MD (SUB_INVESTIGATOR)
Andrea Herr, MD (SUB_INVESTIGATOR)
Louis Aronne, MD (SUB_INVESTIGATOR)
Alpana Shukla, MD (SUB_INVESTIGATOR)
Beverly Tchang, MD (SUB_INVESTIGATOR)
Cleveland ClinicClevelandOhio44195
Rashad Spruill
[email protected]
216-444-1815
Kevin Kruszewski
[email protected]
Roberto Simons-Linares, MD (PRINCIPAL_INVESTIGATOR)
Marcio Griebeler, MD (SUB_INVESTIGATOR)
Baylor College of MedicineHoustonTexas77030
Mercado Michael
[email protected]
713-798-0950
Wasif M Abidi, MD
[email protected]
713-798-0950
Wasif M Abidi, MD (PRINCIPAL_INVESTIGATOR)
Kalpesh Patel, MD (SUB_INVESTIGATOR)
Mandeep Bajaj, MD (SUB_INVESTIGATOR)

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EndocrinologyMetabolic healthWeight loss
By research site
MedStar Health Research Institute· Washington D.C., DCUniversity of Miami Hospital· Miami, FLBrigham and Women's Hospital· Boston, MAMichigan Medicine, Division of Gastroenterology and Hepatology· Ann Arbor, MIWeill Cornell Medicine· New York, NYCleveland Clinic· Cleveland, OH

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