Pilot study to evaluate preliminary safety and efficacy of a novel gastric space occupying device as an aid for weight loss
| ISRCTN | ISRCTN99031557 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99031557 |
| Protocol serial number | PTL-1000-0005-02 |
| Sponsor | Obalon Therapeutics, Inc. (USA) |
| Funder | Obalon Therapeutics, Inc. (USA) |
- Submission date
- 28/01/2011
- Registration date
- 04/03/2011
- Last edited
- 04/03/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Ariel Ortiz
Scientific
Scientific
Obesity Control Center
Avenida Leona Vicario No. 1510
Zona Rio
Tijuana
22320
Mexico
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single centre observational non-randomised unmasked study |
| Secondary study design | Non randomised controlled trial |
| Study type | Participant information sheet |
| 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 |
| Study objectives | 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(s) | 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) |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
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 |
| Completion date | 01/04/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 10 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 12/01/2011 |
| Date of final enrolment | 01/04/2011 |
Locations
Countries of recruitment
- Mexico
Study participating centre
Obesity Control Center
Tijuana
22320
Mexico
22320
Mexico
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
