Study to Evaluate the Full Senseâ?¢ device

Not Applicable

• Conditions: Health Condition 1: E669- Obesity, unspecifiedHealth Condition 2: E119- Type 2 diabetes mellitus without complications

• Registration Number: CTRI/2019/11/021840
• Lead Sponsor: BFKW LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

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

Inclusion Criteria

Screening Visit

1. Subjects aged 22-65 years

2. Diagnosed with T2D for between one and five years inclusive

3. Hemoglobin A1c (HbA1C) of 7.0 â?? 9.5%

4. BMI of 30 to 40 kg/m2

5. History of obesity (BMI >= 30 kg/m2) for at least 6 months

6. Stable weight (no gain or loss over 5% of body weight in the 3 months preceding the Screening Visit)

7. On at least one oral antidiabetic medication at least half maximum labeled dose with no changes in medication in the 12 weeks prior to the Screening Visit

8. Able and willing to follow requirements and visits outlined in the protocol and willing to sign the Informed Consent Form (ICF)

9. For females of child-bearing potential, subject is willing to use contraception and avoid pregnancy during the study

10. Failure of at least one of the following weight loss methods: diet, medications, exercise or behavior modification

Exclusion Criteria

1. Active and uncontrolled GERD defined as Los Angeles Class III or IV erosive esophagitis or greater

2. Hill grade 4 gastroesophageal junction

3. Abnormalities of the GI tract preventing endoscopic access to the esophagus and stomach

4. Anatomic abnormalities in the esophagus or stomach that would preclude the placement of the Full Sense Device procedure

5. Malignancy newly diagnosed by endoscopy

6. Upper gastrointestinal conditions of the stomach and/or esophagus including ulcers, polyps, varices, strictures, congenital or acquired intestinal telangiectasia, hiatal hernia > 3 cm, dysphagia, stricture/stenosis, Barrettâ??s Esophagus, esophageal diverticula, eosinophilic esophagitis

7. History of and/or ongoing clinically significant conditions or disorders of the stomach including, but not limited to, gastroparesis, , chronic gastritis, , chronic upper abdominal pain, chronic nausea, chronic vomiting, chronic dyspepsia or symptoms suggestive of gastroparesis, gastric emptying disorder, including post-prandial fullness or pain, post-prandial nausea or vomiting or early satiety

8. History of and/or ongoing clinically significant conditions or disorders of the esophagus including, but not limited to, , gastroesophageal reflux disease (GERD) refractory to proton pump inhibitor (PPI) therapy, , dysphagia, achalasia, esophageal diverticula, esophageal perforation, eosinophilic esophagitis

9. History of irritable bowel syndrome, radiation enteritis or other inflammatory bowel disease, such as Crohns disease

10. Known autoimmune disease including, but not limited to, celiac disease, systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder

11. Known immunocompromised status including, but not limited to, individuals who have undergone organ transplantation, chemotherapy or radiotherapy within the past 12 months, who have clinically significant leukopenia, who are positive for the human immunodeficiency virus (HIV) or whose immune status makes the subject a poor candidate for clinical trial participation in the opinion of the Investigator

12. Active malignancy within the last 3 years (with the exception of treated basal cell or treated squamous cell carcinoma)

13. Major surgery, surgical biopsy or significant traumatic injury within 3 months prior to enrollment or planned within 1 year

14. Clinically significant and uncontrolled/unstable hepatic (AST, ALT or gamma-glutamyl transferase [GGT] greater than 4 times upper limit), reproductive, gastrointestinal, renal serum creatinine (greater than 180 mmol/L), hematologic, pulmonary, neurologic, respiratory, endocrine, or cardiovascular system diseases

15. Able to tolerate use of PPI 7 days prior to the procedure through 6 month device indwell period

16. Active systemic infection

17. Type I diabetes

18. History of diabetic ketoacidosis or hyperosmolar nonketotic coma

19. History of severe hypoglycemia (more than 1 severe hypoglycemic event, as defined by need for third-party-assistance, in the last year)

20. History of or ongoing use of injectable medications for diabetes (insulin, GLP-1 agonist)

21. Known or suspected allergy to nickel or silicone

22. Ongoing treatment, or anticipated need for treatment with anticoagulants, P2Y12 inhibitors or known gastric irritants such as aspirin (greater than 81 mg) or nonsteroidal ant

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Average relative total body weight loss (%TBWL) at 6 months <br/ ><br>2. Proportion of patients who achieve at least 5% total body weight loss at 6 months <br/ ><br>3. Average change in HbA1c at 6 months <br/ ><br>4. Assessment of all reported adverse events (AE) including serious adverse events (SAE) and Unanticipated Adverse Device Effects (UADE), as well as onset, duration, severity and device- and/or procedure-relatedness of adverse eventsTimepoint: 6 Months

Secondary Outcome Measures

Name	Time	Method
1)Reduction in oral antidiabetic medications <br/ ><br>2)Change in fasting plasma glucose (FPG) <br/ ><br>3)Urine Albumin Creatinine Ratio (UACR) change from baseline <br/ ><br>4) ALT and AST change from baseline <br/ ><br>5) Average relative excess weight loss (%EWL) <br/ ><br>6) Absolute weight loss <br/ ><br>7) Change in BMI <br/ ><br>8) Change in waist and hip circumference <br/ ><br>9) Change in GLP-1, GIP hormones <br/ ><br>10) Change in stomach and small intestinal transit time <br/ ><br>11) Change in basal metabolic rateTimepoint: 6 Months