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Anchorsure Versus Capio for Sacrospinous Ligament Fixation

NCT03565640 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2023-02-16

Study results available
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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.

Conditions

  • Postoperative Pain

Interventions

DEVICE

Capio Slim Device

Participants who have been assigned to sacrospinous ligament fixation for pelvic organ prolapse will have sacrospinous ligament fixation performed with the Capio Slim Device.

DEVICE

Anchorsure Device

Participants who have been assigned to sacrospinous ligament fixation for pelvic organ prolapse will have sacrospinous ligament fixation performed with the Anchorsure Device.

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Catherine Matthews, MD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-29
Primary Completion
2022-01-26
Completion
2022-01-26
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03565640 on ClinicalTrials.gov