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Study to Evaluate Novel Gastric Space Occupying Device

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ClinicalTrials.gov Identifier: NCT01288456
Recruitment Status : Completed
First Posted : February 2, 2011
Last Update Posted : May 28, 2012
Sponsor:
Information provided by (Responsible Party):
Obalon Therapeutics, Inc.

Study Description
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Brief Summary:
This will be an observational, prospective, non-randomized, pilot study to gain initial device experience on a novel space-occupying device in persons who are overweight or obese. No formal hypothesis testing will be conducted.

Condition or disease
Obesity

Study Design
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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: A Single Centre 30-day Observational Non-randomised Study to Evaluate Preliminary Safety and Efficacy of a Novel Gastric Space Occupying Device as an Aid for Weight Loss
Study Start Date : January 2011
Actual Primary Completion Date : February 2011
Actual Study Completion Date : March 2011
Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will be selected from a community sample that satisfy the inclusion/exclusion criteria.
Criteria

Inclusion Criteria:

  1. Age between 21-64 years
  2. BMI 27-40 Kg/m2
  3. No history of weight reduction of more than 5% of total body weight in the past 6 months

Exclusion Criteria:

  1. Have unstable angina, myocardial infarction within the past year, or heart disease classified within the New York Heart Association's Class III or IV functional capacity;
  2. Be taking chronic aspirin or other non steroidal anti-inflammatory agents, or other medications known to be gastric irritants, and unwillingness to discontinue the use of these concomitant medications, antiarrythmics, anti-anginal medications, anticoagulants or medications for congestive heart failure;
  3. Be taking blood pressure medications, unless their blood pressure is controlled and they have been at stable dose for at least 3 months;
  4. Have type 1 diabetes or type 2 diabetes requiring oral medications or insulin;
  5. History or symptoms of thyroid disease which is not controlled by medication;
  6. Have severe renal, hepatic, pulmonary disease or cancer;
  7. Past history of gastrointestinal surgery (excluding uncomplicated appendectomy);
  8. Have a history of adhesive peritonitis;
  9. History or symptoms of esophageal and/or gastric varices;
  10. Have history or congenital or acquired GI anomalies (e.g. atresias, stricture, and /or diverticula);
  11. History or symptoms of inflammatory bowel disease, such as Chron's disease;
  12. History of/ signs and /or symptoms of duodenal or gastric ulcer;
  13. Have gastroparesis;
  14. Pregnant or breastfeeding or intention of becoming pregnant during the study (if female of childbearing potential);
  15. Currently using pharmaceutical agents for weight loss;
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01288456


Locations
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Mexico
Obesity Control Center
Tijuana, Baja California, Mexico
Sponsors and Collaborators
Obalon Therapeutics, Inc.
Investigators
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Principal Investigator: Ariel Ortiz, MD Obesity Control Center
More Information
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Responsible Party: Obalon Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01288456    
Other Study ID Numbers: PTL-1000-0005
First Posted: February 2, 2011    Key Record Dates
Last Update Posted: May 28, 2012
Last Verified: May 2012
Keywords provided by Obalon Therapeutics, Inc.:
medical device, space-occupying device