Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PTL-1000-0005-02
Study information
Scientific title
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
Acronym
Study hypothesis
The study is observational and no formal hypothesis testing will be conducted. The purpose is to evaluate the preliminary safety and effectiveness of the device as an aid to weight loss.
Ethics approval
Ethics Committee of Hospital Angeles in Tijuana, Baja California (Comité de Ética of Hospital Ángeles de Tijuana, Baja California), Mexico, approved on the 15th June 2010 (ref: PTL-1000-0005-02)
Study design
Single centre observational non-randomised unmasked study
Primary study design
Observational
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Overweight, obese
Intervention
This will be an observational study where patients will serve as their own contol. No independent control group will be evaluated. Baseline weight, body mass index (BMI) and waist circumference will be obtained. Space occupying device will be administered and then weight, BMI, waist circumference will be obtained weekly for 4 weeks. At the end of 4 weeks, device will be removed. A last follow up visit/phone contact will occur one week after device removal.
Intervention type
Device
Phase
Not Applicable
Drug names
Primary outcome measures
Safety, characterised by the incidence of all adverse device effects (ADEs), possibly related to or related to the procedure and/or device, experienced by study participants. Adverse device effects are collected at a minimum weekly (day 7, 14, 21, and 28 +/- 2 days); however, they are documented at any time the patient notifies the study staff of a concern. There is no formal endpoint and the sample size does not support a formal endpoint to be evaluated.
Secondary outcome measures
Information on preliminary efficacy, obtained by measurements of total weight loss and excess weight loss during the 30 days of device use as compared to baseline
Overall trial start date
12/01/2011
Overall trial end date
01/04/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged between 21 - 64 years, either sex
2. Body mass index (BMI) 27 - 40 kg/m2
3. No history of weight reduction of more than 5% of total body weight in the past 6 months
4. Must be able to comply with all study requirements for the duration of the study as outlined in the protocol. This includes complying with the visit schedule as well as study specific procedures such as: electrocardiography, endoscopy, upper gastrointestinal radiography, as well as clinical lab testing.
5. Must be able to understand and be willing to provide written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
10
Participant exclusion criteria
1. Have unstable angina, myocardial infarction within the past year or heart disease classified within the New York Heart Association (NYHA) 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 Crohn's disease
12. History of/signs and/or symptoms of duodenal or gastric ulcer
13. Have gastroporesis
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
Recruitment start date
12/01/2011
Recruitment end date
01/04/2011
Locations
Countries of recruitment
Mexico
Trial participating centre
Obesity Control Center
Tijuana
22320
Mexico
Funders
Funder type
Industry
Funder name
Obalon Therapeutics, Inc. (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary