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
Secondary identifying numbers	PTL-1000-0005-02

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

Obesity Control Center
Avenida Leona Vicario No. 1510
Zona Rio
Tijuana
22320
Mexico

Study information

Study design	Single centre observational non-randomised unmasked study
Primary study design	Observational
Secondary study design	Non randomised controlled trial
Study setting(s)	Hospital
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)
Primary outcome measure	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 study start date	12/01/2011
Completion date	01/04/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	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

Sponsor information

Obalon Therapeutics, Inc. (USA)
Industry

5421 Avenida Encinas
Suite F
Carlsbad
92008
United States of America

"ROR"	https://ror.org/03k4rxa78

Funders

Funder type

Industry

Obalon Therapeutics, Inc. (USA)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan