MedTrace Logo

Neujia Anastomosis for Treatment of Obesity and Type II Diabetes

NCT03675074 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-02-04

No results posted yet for this study

Summary

This prospective, multicenter, open label, single arm study will enroll subjects presenting with obesity and inadequately controlled type II diabetes (T2DM). A dual path jejunoileal side-to-side anastomosis is endoscopically created using the Neujia device. Subjects are followed for 12 months and annually thereafter for up to 5 years to assess change in metabolic parameters, medications, weight, and adverse events.

Conditions

Interventions

DEVICE

Neujia

Neujia devices endoscopically deployed for jejunoileal compression anastomosis

Sponsors & Collaborators

  • Neurotronic, Inc.

    lead INDUSTRY

Principal Investigators

  • Irving Waxman, MD · Center Director of The Center for Endoscopic Research and Therapeutics (CERT), University of Chicago Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-12
Primary Completion
2018-12-04
Completion
2019-01-21

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03675074 on ClinicalTrials.gov