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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01288456

Enrollment

Registered

2011-02-02

Start date

2011-01-31

Completion date

2011-03-31

Last updated

2012-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

medical device, space-occupying device

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to 64 Years

Healthy volunteers

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;

Countries

Mexico

Outcome results