Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:16 AM
Study NCT ID:
NCT04855227
Status:
TERMINATED
Last Update Posted:
2024-12-19
First Post:
2021-03-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Prospective Evaluation of Pain After Non-complex Ventral Hernia Repair
Sponsor:
Intuitive Surgical
Organization:
Study Overview
Official Title:
ASPIRE: A proSpective Evaluation of PaIn After Non-complex ventRal hErnia Repair
Status:
TERMINATED
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow rate of enrollment . Additionally it was observed during the course of the trial that changes to the standard of care pain management protocols at some of the institutions, which are not aligned with the study protocol requirements
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ASPIRE
Brief Summary:
The study aims to evaluate outcomes relating to pain and QOL after robotic-assisted or laparoscopic non-complex ventral hernia repair.
Detailed Description:
This is a prospective, observational, study across robotic-assisted and laparoscopic primary (non-recurrent) umbilical and incisional hernia repair. The study aims to evaluate pain and QOL outcomes through 30 days. During the post-operative period through 30 days, pain medication intake, subject reported pain and quality of life and incidence of intra-operative and post-operative adverse events related to the ventral hernia repair will be collected.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: