Neujia Anastomosis for Treatment of Obesity and Type II Diabetes

NCT03675074 | Withdrawn

• 1 other identifier: 450 - NEUJIA 1A Study CIP
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Type2 Diabetes Mellitus; Obesity

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

  6 months

Secondary Outcomes (8)

• Technical and Procedural Success

  1 day

• Composite Safety: percent of subjects with Freedom from bowel perforation, anastomotic leak, stricture, obstruction, and prolonged dumping syndrome (>90 days)

  1, 3, 6, 9, 12, 24, 36, 48, 60 months

• Reversal or Revision Rate

  1, 3, 6, 9, 12, 24, 36, 48, 60 months

• Change in HbA1c

  1, 3, 6, 9, 12, 24, 36, 48, 60 months

• Change in diabetic medications

  1, 3, 6, 9, 12, 24, 36, 48, 60 months

Other Outcomes (1)

• Improvement in metabolic comorbidities

  1, 3, 6, 9, 12, 24, 36, 48, 60 months

Study Arms (1)

Treatment

EXPERIMENTAL

A dual path jejunoileal side-to-side anastomosis is endoscopically created using the Neujia device.

Device: Neujia

Interventions

Neujia DEVICE

Neujia devices endoscopically deployed for jejunoileal compression anastomosis

Treatment

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Type I diabetes, positive autoantibodies to glutamic acid decarboxylase 65 (GAD65), secondary diabetes;
• Hypoglycemia unawareness or serious hypoglycemia with loss of consciousness or confusion sufficient to prevent self-treatment in last 6 months;
• Any condition for which endoscopy or colonoscopy would be contraindicated;
• Any condition for which general anesthesia would be contraindicated;
• Congenital or acquired anomalies of the gastrointestinal (GI) tract, abnormal GI anatomical finding, or anatomy precluding deep small bowel enteroscopy sufficient to prevent endoscopic advancement to the target treatment site;
• Previous laparoscopic or open abdominal or pelvic surgery (except for prior caesarian section or laparoscopic cholecystectomy, which are allowed);
• History of abdominal or pelvic infection or disease or procedures that may have resulted in abdominal adhesions;
• Known history of autoimmune bowel disease or chronic inflammatory bowel disease (IBD);
• Active inflammatory gastrointestinal disease (e.g., pancreatitis, hepatitis) or systemic infection (e.g., tuberculosis, malaria);
• Known history of chronic liver disease (except nonalcoholic steatohepatitis (NASH)/ nonalcoholic fatty liver disease (NAFLD)), hepatic cirrhosis, or current transaminase/alkaline phosphatase elevation above three times the upper limit of normal (in the absence of NASH/NAFLD);
• Severe or unstable pulmonary or circulatory comorbidities posing risks to the patient that may confound the results of the study in investigator's judgment;
• History of cardiovascular event within last 6 months or with chronic sequela;
• Uncontrolled hypertension with systolic blood pressure (SBP) over 160 mmHg or diastolic blood pressure (DBP) over 110 mmHg;
• Estimated glomerular filtration rate (eGFR) \< 30 mL/min per 1.73 m2;
• Currently taking pre-meal, bolus, or premixed insulin (patients on basal insulin only are allowed);

Sponsors & Collaborators

• Neurotronic, Inc.: lead

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Irving Waxman, MD

  Center Director of The Center for Endoscopic Research and Therapeutics (CERT), University of Chicago Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: September 18, 2018
• Study Start: September 12, 2018
• Primary Completion: December 4, 2018
• Study Completion: January 21, 2019
• Last Updated: February 4, 2019

Record last verified: 2019-01