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NCT03565640 · ClinicalTrials.gov registry record · NA
Anchorsure Versus Capio for Sacrospinous Ligament Fixation
A NA study, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- NA
- Development phase
- 48
- Enrollment target
NCT03565640: Completed NA study, sponsored by Wake Forest University Health Sciences.
NCT03565640 is a NA study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 48 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03565640, a NA study, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- NA
- Development phase
- 48 participants
- Enrollment target
Study Summary
Sacrospinous ligament fixation is a common method of repairing apical support for pelvic organ prolapse but it currently suffers from a high rate of postoperative buttock and posterior thigh pain. Anchorsure® is a relatively new FDA-approved device that uses an anchor instead of the widely-used suture capturing mechanism to perform sacrospinous ligament fixation. The study hypothesis is that Anchorsure® will reduce the degree and rate of buttock and posterior thigh pain compared to the widely used Capio™ Slim suturing capturing Device.
Primary Outcome
This will be assessed using the numeric rating scale (NRS). The score is 0-10, with higher scores denoting a greater degree of pain.
Interventions
- DEVICE Capio Slim Device
- DEVICE Anchorsure Device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2018-10-29 |
| Est. Completion | 2022-01-26 |
| Phase | NA |
What the finished NCT03565640 record still lists
NCT03565640 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Capio Slim Device is the first listed.
NCT03565640 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03565640 about?
NCT03565640 is a clinical study titled "Anchorsure Versus Capio for Sacrospinous Ligament Fixation". Sacrospinous ligament fixation is a common method of repairing apical support for pelvic organ prolapse but it currently suffers from a high rate of postoperative buttock and posterior thigh pain. Anchorsure® is a relatively new FDA-approved device that uses an anchor instead of the widely-used sutu...
What is the current status of trial NCT03565640?
This trial is currently completed. It is a NA study. The enrollment target is 48 participants. The study started on 2018-10-29. Estimated completion is 2022-01-26.
What interventions are being tested in trial NCT03565640?
The interventions under investigation include: Capio Slim Device (DEVICE), Anchorsure Device (DEVICE).
Who is sponsoring clinical trial NCT03565640?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03565640's enrollment target sits among peer trials
48 1381st of 2000 higher than 601 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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