Assessing the safety and effectiveness of the BariClip device in the treatment of severe obesity in Jorda

Not Applicable

• Conditions: Obesity and its associated disorders; Nutritional, Metabolic, Endocrine; Obesity

• Registration Number: ISRCTN98465849
• Lead Sponsor: Jordan Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-16
• Last Update Posted: 27 February 2023
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Age 18 – 65 years
2. Male or female
3. BMI >40 kg/m² and BMI >30 kg/m² with at least one comorbid condition (hypertension [HTN], type 2 diabetes [DT2], sleep apnea)
4. Willingness to comply with the substantial lifelong dietary restrictions required by the procedure (written consent form)
5. History of obesity for at least 5 years
6. History of failure with dieting methods
7. Willingness to follow protocol requirements including signed consent, routine follow-up schedule, completing quality of life (QOL) questionnaires, completing laboratory tests, completing diet and behavior modification counseling
8. Residing within a reasonable distance from an investigating center and able to travel to the investigator to complete all routine follow-up visits

Exclusion Criteria

1. Surgery or treatment represents an unreasonable risk to the subject
2. Patient history of inflammatory disease of the gastrointestinal (GI) tract (including ulceration, duodenal ulceration, grade 4 esophagitis, specific inflammation such as Crohn’s disease or ulcerative colitis)
3. Severe cardiopulmonary disease or other serious organic disease
4. Severe coagulopathy, upper gastrointestinal (UGI) bleeding conditions, such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia
5. Congenital or acquired anomalies of the GI
6. Severe hiatal hernia (>3 cm)
7. Pregnant or has the intention of becoming pregnant in the next 12 months
8. Alcohol or drug addiction, active smoker
9. Mental retardation or emotional instability, or psychological characteristics which, in the opinion of the investigators, make the subject a poor candidate for clip surgery
10. Previous esophageal, gastric surgery, hepatectomy, splenectomy
11. Previous endoscopic procedure for obesity
12. Patient under GLP1 medication or weight loss drug
13. Diabetes patient under treatment for gastroparesis
14. Previous bariatric surgery, intestinal obstruction, or adhesive peritonitis
15. Patient history of a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma, or other autoimmune connective tissue disorder
16. Participating in another ongoing clinical trial in which concomitant diagnosis or therapeutic intervention would adversely affect the integrity of the Clip clinical trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percent Excess Weight Loss (%EWL) defined as weight loss divided by baseline excess weight. Excess weight will be determined from ideal body weight based on a BMI of 24.9 for normal adults (Center for Disease Control [CDC]) at 1, 3, 6, 12, 18, 24, 36, 48, and 60 months post-implantation.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Absolute weight loss over 60 months, defined simply as the total weight loss for the follow-up period<br> 2. Total change in weight (TWL%) defined as (preoperative (preop) weight – follow up weight)/(preop weight) X 100%, measured at 12, 36 and 60 months<br> 3. Total change in BMI (TBMIL%) defined as (preoperative (preop) BMI – follow up BMI)/(preop BMI) X 100%, measured at 12, 36 and 60 months<br> 4. Plasma glucose levels, HbA1c levels, and resolution of T2DM (% of patients, defined as HbA1C<6) in diabetic patients measured annually over 5 years<br>