Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:42 AM
Study NCT ID:
NCT02487602
Status:
COMPLETED
Last Update Posted:
2016-08-23
First Post:
2015-06-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Scintigraphic Study to Investigate the Effect of Gelesis100 on Gastric Emptying in Overweight and Obese Subjects
Sponsor:
Gelesis, Inc.
Organization:
Study Overview
Official Title:
A Randomized, Partially-blinded, Cross-over Scintigraphic Study to Investigate the Effect of Gelesis100 on Gastric Emptying in Overweight and Obese Subjects
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to evaluate the gastrointestinal behaviour of a novel weight loss device in vivo to further understand the device's mechanism of action in aiding weight loss.
Detailed Description:
Gelesis100 is a new, experimental medical device which has been developed by Gelesis, Inc. to aid weight loss in overweight/obese patients by reducing the amount of food required to make them feel full. The device is contained in a capsule which is swallowed with water before a meal. Once swallowed, the capsule dissolves and the capsule contents hydrate and mix with the food in the stomach, creating a feeling of fullness.
Four different treatments of up to 5 capsules each will be given to participants during this study. These will be a mixture of the Gelesis100 capsules and capsules which do not contain the device i.e., they are placebo (will contain sucrose \[sugar\])
The study is designed to look at:
* The time it takes for the stomach to empty once receiving each treatment
* The time it takes for food and Gelesis100 to travel through the intestine
* The effects of Gelesis100 on the feeling of satiety (how full participants feel)
In order to monitor gastrointestinal behavior, either a small amount of radioactive material will be added to a component of a standard lunch or to the water given with the treatment. The radiation emitted will then be detected as it travels through the GI tract by taking images using a device known as a gamma camera. The procedure is relatively easy and non- invasive.
Four different treatments of up to 5 capsules each will be given to participants during this study. These will be a mixture of the Gelesis100 capsules and capsules which do not contain the device i.e., they are placebo (will contain sucrose \[sugar\])
The study is designed to look at:
* The time it takes for the stomach to empty once receiving each treatment
* The time it takes for food and Gelesis100 to travel through the intestine
* The effects of Gelesis100 on the feeling of satiety (how full participants feel)
In order to monitor gastrointestinal behavior, either a small amount of radioactive material will be added to a component of a standard lunch or to the water given with the treatment. The radiation emitted will then be detected as it travels through the GI tract by taking images using a device known as a gamma camera. The procedure is relatively easy and non- invasive.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: