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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02003872
Recruitment Status : Terminated (Stopeed due to lack of recruitment)
First Posted : December 6, 2013
Last Update Posted : December 22, 2015
Information provided by (Responsible Party):
Dr. Alon Lang, 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.

Condition or disease Intervention/treatment Phase
Obesity Diabetes Hypertension Device: Spatz 3 intragastric balloon Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Long Term Effect of Adjustable Spaatz 3 Intragastric Balloon on Weight Loss
Study Start Date : January 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Spattz 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
Device: Spatz 3 intragastric balloon
Intra gastric balloon implanted using gastroscopy

Primary Outcome Measures :
  1. Excess weight loss [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. liver fat infiltration [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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.

    6. 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.

    10. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02003872

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Sheba Medical Center
Ramat Gan, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
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Principal Investigator: Alon Lang, MD Sheba Medical Center
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Responsible Party: Dr. Alon Lang, Senior physician GI department, Sheba Medical Center Identifier: NCT02003872    
Other Study ID Numbers: 0670-13-SMC
First Posted: December 6, 2013    Key Record Dates
Last Update Posted: December 22, 2015
Last Verified: December 2015
Additional relevant MeSH terms:
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Weight Loss
Body Weight Changes
Body Weight