Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2025-12-27 @ 10:02 PM
Study NCT ID:
NCT04919395
Status:
TERMINATED
Last Update Posted:
2024-01-22
First Post:
2021-05-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preliminary Evaluation of a "Clip" Device for Contraceptive Implant Removal
Sponsor:
University of Michigan
Organization:
Study Overview
Official Title:
Evaluation of a "Clip" Device Added to the Current Standard Removal of Contraceptive Implant to Improve Stability of the Implant, Shorten Removal Time, and Increase the Ease of Removal
Status:
TERMINATED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
On the single day that the study was open, it became clear that modifications to the clip would be required. Only late in 2023 did it become clear that any continuation of the project would require a new trial.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial is being completed to understand how the study "Clip" device works when assisting clinicians with Nexplanon removals. The study device clips to the skin to hold the implant still and raise the tip of the implant during removal. The study device may improve the process for removing under arm implants by decreasing procedure time and improving the ease and safety of the procedure.
The results from this study will help the researchers understand whether the study device has the potential to simplify the removal procedure and make this form of birth control safer for patients.
The results from this study will help the researchers understand whether the study device has the potential to simplify the removal procedure and make this form of birth control safer for patients.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
False
Is an FDA AA801 Violation?: