A non-invasive swallowable device for weight loss and obesity-related comorbidities

Completed

• Conditions: Obesity, overweight; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN53040076
• Lead Sponsor: niversity of Rome - La Sapienza (Italy)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-14
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Obese (BMI > 30) and overweight (BMI > 27) patients
2. Both male and female
3. Aged over 18 years

Exclusion Criteria

1. Anatomical abnormalities of the upper gastrointestinal (GI) tract
2. Functional disorders of the upper GI tract
3. Inflammatory and other pathophysiological conditions of the GI tract
4. Chronic or acute use of medications known to affect integrity of the GI tract and/or weight
5. Prior GI tract surgeries excluding uncomplicated appendectomies
6. Untreated hypothyroidism or untreated Cushing?s disease or syndrome
7. Severe, unstable/uncontrolled medical conditions of major organ systems
8. Alcohol and/or illicit drugs abuse
9. Undergoing chronic steroid or immunosuppressive therapy
10. Pregnant or breastfeeding or intention of becoming pregnant during the study
11. Have type 1 diabetes mellitus
12. Must not undertake scuba diving or travel in an unpressurized airplane cabin
13. Known allergies to products/foods of porcine origin
14. Untreated Heliocobacter pylori infection

Study & Design

• Study Type: Interventional
• Study Design: Not specified