Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06185088
Status:
TERMINATED
Last Update Posted:
2023-12-29
First Post:
2023-12-14
Brief Title:
MENDD Tolerance Assessment Study
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
Michigan ENdoluminal Distraction Device MENDD Tolerance Assessment Study
Status:
TERMINATED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Initial PI departed institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will utilize approved devices in an off-label manner to create forces required to induce intestinal lengthening Radial and longitudinal forces are both required and two devices will be used to create forces in order to test tolerability of said forces This is to provide evidence that humans could tolerate the forces produced by a proposed commercially built device
This study will test the hypothesis that radial and longitudinal forces necessary to produce enterogenesis will cause low levels of discomfort in healthy adults Approved devices will be utilized in an off-label manner to reproduce forces similar to our novel medical device which is designed to treat short bowel syndrome SBS
This trial will not be testing a treatment for SBS and individuals with SBS are ineligible for recruitment
This study will test the hypothesis that radial and longitudinal forces necessary to produce enterogenesis will cause low levels of discomfort in healthy adults Approved devices will be utilized in an off-label manner to reproduce forces similar to our novel medical device which is designed to treat short bowel syndrome SBS
This trial will not be testing a treatment for SBS and individuals with SBS are ineligible for recruitment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None