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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 by Sheba Medical Center
Sponsor:
Information provided by (Responsible Party):
Dr. Alon Lang, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT02003872
First received: December 2, 2013
Last updated: December 22, 2013
Last verified: December 2013
  Purpose

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 Intervention
Obesity
Diabetes
Hypertension
Device: Spatz 3 intragastric balloon

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Long Term Effect of Adjustable Spaatz 3 Intragastric Balloon on Weight Loss

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

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: 25
Study Start Date: December 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
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

Contacts
Contact: Alon Lang, MD 3-5302909 langa@sheba.health.gov.il

Locations
Israel
Sheba Medical Center Not yet recruiting
Ramat Gan, Israel, 52621
Contact: Alon Lang, MD    972-3-5302909    langa@sheba.health.gov.il   
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Alon Lang, MD Sheba Medical Center
  More Information

No publications provided

Responsible Party: Dr. Alon Lang, Senior physician GI department, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02003872     History of Changes
Other Study ID Numbers: 0670-13-SMC
Study First Received: December 2, 2013
Last Updated: December 22, 2013
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Hypertension
Obesity
Weight Loss
Vascular Diseases
Cardiovascular Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on July 23, 2014