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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02003872
• Other study ID #: 0670-13-SMC
• Status: Terminated
• Phase: N/A
• First received: December 2, 2013
• Last updated: December 21, 2015
• Start date: January 2015
• Est. completion date: November 2015

Study information

• Verified date: December 2015
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Hypertension
• Obesity

Intervention

Device:
• Spatz 3 intragastric balloon
Intra gastric balloon implanted using gastroscopy

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Excess weight loss		2 years	No
Secondary	liver fat infiltration		2 years	No