Condition category
Nutritional, Metabolic, Endocrine
Date applied
28/01/2011
Date assigned
04/03/2011
Last edited
04/03/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ariel Ortiz

ORCID ID

Contact details

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

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

Sponsor information

Organisation

Obalon Therapeutics, Inc. (USA)

Sponsor details

5421 Avenida Encinas
Suite F
Carlsbad
92008
United States of America

Sponsor type

Industry

Website

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

Publication citations

Additional files

Editorial Notes