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Mesh
Randomized Trial of Y Mesh vs Dual Mesh
Cleveland, OH
N/A
Waitlist Available
Led By Cecile Unger, M.D.
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group
Summary
The primary objective of the proposed study is to determine the difference in suturing time when using the restorelle Y mesh versus the restorelle dual flat mesh at the time of laparoscopic and robotic-assisted laparoscopic sacrocolpopexy. Hypothesis: Suturing time when using the restorelle Y mesh will be faster than when using the restorelle dual flat mesh at the time of laparoscopic and robotic-assisted laparoscopic sacrocolpopexy.
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Eligible Conditions
- Use of Pessary to Reduce Prolapse
- Prolapse
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Post-operative Mean Difference POPDI at 24 Months
Postoperative Mean Difference CRADI at 24 Months
Postoperative Mean Difference UDI at 24 Months
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Cololast, Inc. Restorell Y meshActive Control1 Intervention
Y mesh
Group II: Coloplast, Inc. Restorelle Dual flat meshActive Control1 Intervention
Dual flat mesh
Find a Location
Closest Location:Cleveland Clinic· Cleveland, OH
Who is running the clinical trial?
The Cleveland ClinicLead Sponsor
1,063 Previous Clinical Trials
1,375,710 Total Patients Enrolled
Cecile Unger, M.D.Principal InvestigatorThe Cleveland Clinic
1 Previous Clinical Trials
46 Total Patients Enrolled