Study to evaluate the safety and efficacy of NobiX system.

Not Applicable

• Conditions: Health Condition 1: E119- Type 2 diabetes mellitus without complications

• Registration Number: CTRI/2022/05/042448
• Lead Sponsor: Allevetix Medical Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Male and female patients

2. Patient is at least 18 years old

3. Anticipated life expectancy of at least 1 year from enrolment

4. Patient providing written Informed Consent prior to any study related procedures

5. Patient is willing to comply with the Clinical Investigational Plan (CIP) requirements including return to the study center for all required clinical evaluations

6. Patients with baseline BMI of greater than equal to 30 kg per m2 and less than equal to 45 kg per m2

7. Type II Diabetes mellitus with HbA1c greater than equal to 7 in the 6 months before enrolment

8. Sexually active women, unless surgically sterile or post-menopausal, must use one of the

following methods to avoid pregnancy during the study:

1. Abstinence from penile/vaginal intercourse during the study;

2. Double barrier contraceptive methods one of which must be a condom

Exclusion Criteria

1. Use of weight loss medications, or appetite suppressants during one month prior to enrollment.

2. Use of non-steroidal anti-inflammatory drugs, corticosteroids, and drugs known to affect gastrointestinal motility during 3 months prior to enrollment.

3. Patients who have taken Antiplatelet medications, Coumadin or Direct Oral Anti-coagulants 10 days prior to the device placement.

4. Recent Pancreatitis in the last 1 month, any history of coronary artery disease, Chronic Obstructive Pulmonary Disease (COPD), biliary disease (gallstone, choledocholithiasis), severe coagulopathy.

5. History of congenital or acquired gastrointestinal tract disorders, including gastrointestinal bleeding conditions

6. Patients having anemia/ iron deficiency

7. Patients with known peptic ulcer, gastritis, duodenitis, esophagitis, varices

8. History or symptoms of scleroderma

9. Previous surgery in the gastrointestinal tract that could affect the ability to place the study device

10. Current active infection (excluding H. pylori infection for which antibiotic treatment is initiated10 days before device implantation)

11. Any malignancy

12. HIV, HCV, HBV positive

13. Alcohol abuse

14. Pregnant female or intention to become pregnant during the study period

15. Patients with confirmed novel coronavirus infection (COVID-19)

16. Any other medical condition or serious intercurrent illness that, in the opinion of the Principal Investigator, may make it undesirable for the patient to participate in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified