Single Arm Study of Neurotronic Fully Endoscopic Jejunoileal Side-to-side Anastomosis for Treatment of Obesity and Type II Diabetes: The Neujia 1A Trial

Status: Withdrawn
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Maximum Age: 65
Healthy Volunteers: No
View:

• Age ≥ 22 and < 65 years, estimated life expectancy ≥ 2 years;

• BMI ≥ 30 and < 40 kg/m2;

• HbA1c ≥ 8.0 and ≤ 11%;

• Fasting Glucose (FG) ≥ 126 mg/dL;

• Under active medical care with ≥ 6-months treatment on ≥ 2 anti-diabetic medications;

• T2DM diagnosed ≤ 10 years prior to enrollment;

• Non-fasting random or stimulated C-peptide ≥ 2 ng/mL (660 pmol/l);

• Willing and able to provide informed consent, comply, and be geographically stable

Time Frame
Start Date: September 12, 2018
Completion Date: January 21, 2019
Treatments
Experimental: Treatment
A dual path jejunoileal side-to-side anastomosis is endoscopically created using the Neujia device.
Authors
Irving Waxman, Jorge Orillac, Jose Dutari, Guadalupe L Perez, Tomas Hucl, Martin Haluzik, Jan Martinek
Sponsors
Leads: Neurotronic, Inc.

This content was sourced from clinicaltrials.gov

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