The Long Term Effect of Adjustable Spaatz 3 Intragastric Balloon on Weight Loss

Not Applicable

Terminated

• Conditions: Hypertension; Obesity; Diabetes
• Interventions: Device: Spatz 3 intragastric balloon

• Registration Number: NCT02003872
• Lead Sponsor: Sheba Medical Center

Brief Summary

This is an open-label trial investigating the effect of Spatz 3 intragastric balloon on weight loss on obesity and associated co- morbidities.

The study aim is to evaluate the effect of the intra gastric balloon on weight reduction and on related co- morbidities during 1 year of balloon implantation and a year following explantation.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-12-02
• Study First Submitted QC: 2013-12-02
• Study First Posted: 2013-12-06
• Study Start: 2015-01
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-21
• Last Update Posted: 2015-12-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• 1. Subjects willing to comply with study requirements and have signed an informed consent form.

2. Age 18-70 3. BMI ≥ 35 kg/m² or BMI ≥ 30 kg/m² and hypertension or diabetes mellitus 4. Documented negative pregnancy test in women of childbearing potential. 5. Women of childbearing potential agree to remain on contraceptives for the duration of their trial participation.

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Exclusion Criteria

• 1. Subjects receiving any prescription or over the counter weight loss medication within 30 days prior to randomization (including GLP-1 analogs).

  2. Previous GI surgery that could preclude the ability to place the device. 3. Subjects with a history of abnormal GI anatomical findings documented on imaging study, which in the opinion of the investigator, may impair implantation of the IGB device 4. Subjects with severe GERD that are not responding to Proton Pump Inhibitor (PPI) 5. Known abnormal pathologies or conditions of the upper gastrointestinal tract.

  3. Subjects with symptomatic gallstones within 6 months prior to randomization 7. Coagulopathy defined as hgb <10g/dl and platelet < 100,000/ml or diagnosis of hemophilia, factor X deficiencies or fibrinogen abnormalities 8. Subjects requiring prescription antithrombotic therapy (i.e. anticoagulant or antiplatelet agent) 9. Subjects unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) or any other drugs with bleeding as a potential side effect during the study duration.

  4. Subject is or has been enrolled in another investigational study within 3 months of participation into the current study 11. Subjects not residing within a 3 hour driving distance of the study center.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Spattz 3 intragastric balloon	Spatz 3 intragastric balloon	obese patients, . BMI ≥ 35 kg/m² or BMI ≥ 30 kg/m² and hypertension or diabetes mellitus. All will have the intragastric balloon

Primary Outcome Measures

Name	Time	Method
Excess weight loss	2 years

Secondary Outcome Measures

Name	Time	Method
liver fat infiltration	2 years

Trial Locations

Locations (1)

Sheba Medical Center; 🇮🇱 Ramat Gan, Israel