RESET System Pivotal Trial (Rev F)

NARecruitingINTERVENTIONAL
Enrollment

264

Participants

Timeline

Start Date

September 9, 2019

Primary Completion Date

December 1, 2025

Study Completion Date

December 1, 2026

Conditions
Diabetes type2Obesity
Interventions
DEVICE

RESET Liner

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.

OTHER

Sham

Patient receives upper endoscopy but no treatment

Trial Locations (7)

10021

RECRUITING

Weill Cornell Medicine, New York

20010

RECRUITING

MedStar Health Research Institute, Washington D.C.

33166

RECRUITING

University of Miami Hospital, Miami

44195

RECRUITING

Cleveland Clinic, Cleveland

48109

RECRUITING

Michigan Medicine, Division of Gastroenterology and Hepatology, Ann Arbor

77030

RECRUITING

Baylor College of Medicine, Houston

02115

RECRUITING

Brigham and Women's Hospital, Boston

Sponsors
All Listed Sponsors
collaborator

Biostatistical Consulting, Inc.

OTHER

lead

Morphic Medical Inc.

INDUSTRY

NCT04101669 - RESET System Pivotal Trial (Rev F) | Biotech Hunter | Biotech Hunter