The Long Term Effect of Adjustable Spaatz 3 Intragastric Balloon on Weight Loss
Verified November 2014 by Sheba Medical Center
Information provided by (Responsible Party):
Dr. Alon Lang, Sheba Medical Center
First received: December 2, 2013
Last updated: November 18, 2014
Last verified: November 2014
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.
Device: Spatz 3 intragastric balloon
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||The Long Term Effect of Adjustable Spaatz 3 Intragastric Balloon on Weight Loss
Primary Outcome Measures:
- Excess weight loss [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- liver fat infiltration [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2015 (Final data collection date for primary outcome measure)
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
|Ages Eligible for Study:
||18 Years to 70 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02003872
Sheba Medical Center
||Alon Lang, MD
||Sheba Medical Center
No publications provided
ClinicalTrials.gov processed this record on February 27, 2015
||Dr. Alon Lang, Senior physician GI department, Sheba Medical Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 2, 2013
||November 18, 2014
||Israel: Ministry of Health