Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00128284
Status:
COMPLETED
Last Update Posted:
2008-05-22
First Post:
2005-08-08
Brief Title:
A Comparison of SmartPill Capsule With Scintigraphy for Determining Gastric Residence Time
Sponsor:
The SmartPill Corporation
Organization:
The SmartPill Corporation
Study Overview
Official Title:
A Comparison Trial of SmartPill Corporation GI Monitoring System With Scintigraphic Gastric Emptying Procedure for Determining Gastric Residence Time
Status:
COMPLETED
Status Verified Date:
2008-05
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 this study is to determine the correlation between gastric residence time of the SmartPill Capsule and the time required for partial emptying of a standard radiolabeled meal as measured by gastric emptying scintigraphy
Detailed Description:
Gastric emptying scintigraphy is considered the gold standard for evaluating gastric emptying and is widely available Accurate characterization of gastric emptying may guide medical and surgical treatment choices In addition these techniques may allow for monitoring of therapeutic results for follow-up patient management
The SmartPill GI Monitoring System offers an alternative non-invasive method for characterizing disorders of the stomach The system consists of an ingestible capsule that houses sensors for pH temperature and pressure a receiver for receiving and storing signals from the capsule and software for displaying data on a personal computer The capsule samples at regular intervals and transmits the sensed pH pressure and temperature data to a portable receiver worn by the subject After test completion the recorded data is downloaded to a personal computer for subsequent evaluation
The SmartPill GI Monitoring System offers an alternative non-invasive method for characterizing disorders of the stomach The system consists of an ingestible capsule that houses sensors for pH temperature and pressure a receiver for receiving and storing signals from the capsule and software for displaying data on a personal computer The capsule samples at regular intervals and transmits the sensed pH pressure and temperature data to a portable receiver worn by the subject After test completion the recorded data is downloaded to a personal computer for subsequent evaluation
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIH DK069614 | None | None | None |
| NYSTAR C020118 | None | None | None |