NCT01718886

Brief Summary

The objective of this study is to evaluate the initial safety and preliminary effectiveness of the Obalon intragastric balloon system in European subjects with a BMI in the range of 27 - 35 kg/m\^2

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2012

Shorter than P25 for all trials

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2012

Completed
Last Updated

October 31, 2012

Status Verified

October 1, 2012

Enrollment Period

4 months

First QC Date

October 29, 2012

Last Update Submit

October 29, 2012

Conditions

ObesityWeight Control

Keywords

ObesityWeight lossWeight controlIntragastric balloongastric balloon

Outcome Measures

Primary Outcomes (2)

  • Percent Excess Weight Loss based on an ideal BMI of 25.

    12 weeks

  • Assessment of all adverse events.

    12 weeks

Study Arms (1)

Obalon Gastric Balloon

Patients received 1-3 Obalon Gastric Balloons over a period of 12 weeks

Device: Obalon Gastric Balloon

Interventions

Obalon Gastric BalloonDEVICE
Obalon Gastric Balloon

Eligibility Criteria

Age21 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients were selected from investigators' patient population and included patients with a BMI in the range of 27 - 35 kg/m\^2

You may qualify if:

  • Were between 21-64 years of age;
  • Had a BMI 27-35 Kg/cm
  • Did not have a history of weight reduction over 5% of body weight over the past 6 months
  • Were able to comply with all study requirements for the duration of the study as outlined in the protocol. This included complying with the visit schedule as well as study specific procedures such as: electrocardiography, endoscopy, upper gastrointestinal radiography and clinical lab testing
  • Were able to understand and willing to provide written informed consent

You may not qualify if:

  • Experienced any difficulty in swallowing;
  • Had 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;
  • Taking chronic aspirin or other non steroidal anti-inflammatory agents, or other medications known to be gastric irritants, and not willingness to discontinue the use of these concomitant medications, antiarrythmics, anti-anginal medications, anticoagulants or medications for congestive heart failure;
  • Taking blood pressure medications, unless their blood pressure was controlled and they have been at stable dose for at least 3 months;
  • Had type 1 diabetes or Type 2 diabetes requiring oral medications or insulin;
  • Had a history or symptoms of thyroid disease which is not controlled by medication;
  • Had severe renal, hepatic, pulmonary disease or cancer;
  • Had past history of gastrointestinal surgery (excluding uncomplicated appendectomy);
  • Had any abnormal stenosis or obstruction of the GI tract;
  • Had a history of adhesive peritonitis;
  • Had a previously diagnosed hiatal hernia greater than 2cm;
  • Had any abnormality of the esophagus, stomach or pylorus;
  • Had history of severe esophagitis;
  • Had history or symptoms of esophageal and/or gastric varices;
  • Had history or congenital or acquired GI anomalies (e.g. atresias, stricture, and /or diverticula);
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Gastroenterology, Erasme Hospital

Brussels, 6B1070, Belgium

Location

Service D'exploration Functionelle Digestive, Hospital Edouard Harriot

Lyon, Cedex, 69473, France

Location

Related Links

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Fancois Mion, MD

    Hospital Edouard Harriot

    PRINCIPAL INVESTIGATOR

  • Jacques Deviere

    Erasme University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2012

First Posted

October 31, 2012

Study Start

January 1, 2012

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

October 31, 2012

Record last verified: 2012-10

Locations

BE(1)FR(1)