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Study to Evaluate Novel Gastric Space Occupying Device

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Obalon Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01288456
First received: January 31, 2011
Last updated: May 25, 2012
Last verified: May 2012

January 31, 2011
May 25, 2012
January 2011
February 2011   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01288456 on ClinicalTrials.gov Archive Site
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Study to Evaluate Novel Gastric Space Occupying Device
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

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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

Patients will be selected from a community sample that satisfy the inclusion/exclusion criteria.

Obesity
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
March 2011
February 2011   (final data collection date for primary outcome measure)

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;
Both
21 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT01288456
PTL-1000-0005
No
Obalon Therapeutics, Inc.
Obalon Therapeutics, Inc.
Not Provided
Principal Investigator: Ariel Ortiz, MD Obesity Control Center
Obalon Therapeutics, Inc.
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP