Study to Evaluate Novel Gastric Space Occupying Device

NCT01288456 | Completed

• 1 other identifier: PTL-1000-0005
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

medical device, space-occupying device

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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;
• 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;
• Be taking blood pressure medications, unless their blood pressure is controlled and they have been at stable dose for at least 3 months;
• Have type 1 diabetes or type 2 diabetes requiring oral medications or insulin;
• History or symptoms of thyroid disease which is not controlled by medication;
• Have severe renal, hepatic, pulmonary disease or cancer;
• Past history of gastrointestinal surgery (excluding uncomplicated appendectomy);
• Have a history of adhesive peritonitis;
• History or symptoms of esophageal and/or gastric varices;
• Have history or congenital or acquired GI anomalies (e.g. atresias, stricture, and /or diverticula);
• History or symptoms of inflammatory bowel disease, such as Chron's disease;
• History of/ signs and /or symptoms of duodenal or gastric ulcer;
• Have gastroparesis;
• Pregnant or breastfeeding or intention of becoming pregnant during the study (if female of childbearing potential);
• Currently using pharmaceutical agents for weight loss;

Sponsors & Collaborators

• Obalon Therapeutics, Inc.: lead

Study Sites (1)

Obesity Control Center

Tijuana, Estado de Baja California, Mexico

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ariel Ortiz, MD

  Obesity Control Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2011
• First Posted: February 2, 2011
• Study Start: January 1, 2011
• Primary Completion: February 1, 2011
• Study Completion: March 1, 2011
• Last Updated: May 28, 2012

Record last verified: 2012-05

Locations

ME (1)