Pilot Study to Evaluate A Novel Gastric Space Occupying Device

NCT01444274 | Completed

• 1 other identifier: PTL-1000-0012
• 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

Study Arms (1)

Obalon Gastric Balloon

One or two balloons administered to each patient

Device: Obalon Gastric Balloon(s)

Interventions

Obalon Gastric Balloon(s) DEVICE

One or two balloons administered per patient

Obalon Gastric Balloon

Eligibility Criteria

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

Study Population

Overweight or obese individuals who have failed routine dieting in the past

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, 22320, 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 Lagardere, 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: September 28, 2011
• First Posted: September 30, 2011
• Study Start: July 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: March 15, 2019

Record last verified: 2019-03

Locations

ME (1)