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

Study on a non-invasive swallowable device for weight loss and obesity-related comorbidities in overweight and obese patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN53040076

Enrollment

200

Registered

2013-10-14

Start date

2013-06-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, overweight Nutritional, Metabolic, Endocrine

Interventions

A new intragastric balloon, Obalon® Gastric Balloons (OGB) (ObalonTherapeutics, Inc., Carlsbad, San Diego, California) will be inserted. Obalon is a gas-filled balloon with a maximal volume of 250 ml

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Weight loss parameters: Body Mass Index (BMI), Excess Weight Loss (EWL) percentage, weight loss (WL percentage. They will be evaluated at baseline, three months and follow-up.	—

Secondary

Measure	Time frame
1. Pain and post placement discomfort, measured using the Visual Analogue Scale (VAS) score (0 = no pain, 10 = unbearable pain) at baseline, three months and follow-up 2. Changes in comorbidities - diabetes type 2 : measured by fasting glycemia, Hb1ac 3. Changes in comorbidities - hypertension: measured by changes in pharmacological therapy, systolic and diastolic pressure 4. Changes in comorbidities - obstructive sleep apnea syndrome (OSAS): measured by changes in pharmacological therapy (if present), apnea/hypopnea index and oxygen saturation, changes in oxygen therapy (C-PAP) if present	—

Measure

Time frame

1. Pain and post placement discomfort, measured using the Visual Analogue Scale (VAS) score (0 = no pain, 10 = unbearable pain) at baseline, three months and follow-up 2. Changes in comorbidities - diabetes type 2 : measured by fasting glycemia, Hb1ac 3. Changes in comorbidities - hypertension: measured by changes in pharmacological therapy, systolic and diastolic pressure 4. Changes in comorbidities - obstructive sleep apnea syndrome (OSAS): measured by changes in pharmacological therapy (if present), apnea/hypopnea index and oxygen saturation, changes in oxygen therapy (C-PAP) if present

—

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026