Pilot Study to Evaluate A Novel Gastric Space Occupying Device

Obesity Clinical Trial

Official title:

A Single-Center 60-day Observational, Non-randomized Study to Evaluate Safety and Preliminary Efficacy of a Novel Gastric Space Occupying Device as an Aid for Weight Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01444274
• Other study ID #: PTL-1000-0012
• Status: Completed
• Start date: July 2011
• Est. completion date: September 2011

Study information

• Verified date: March 2019
• Source: Obalon Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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;

Related Conditions & MeSH terms

• Obesity

Intervention

Device:
• Obalon Gastric Balloon(s)
One or two balloons administered per patient

Locations

Country	Name	City	State
Mexico	Obesity Control Center	Tijuana	Baja California

Sponsors (1)

Lead Sponsor	Collaborator
Obalon Therapeutics, Inc.

Country where clinical trial is conducted

Mexico,