Status:
COMPLETED
Safety and Efficacy of a Transvaginal Suture Capturing Mesh Device
Lead Sponsor:
Karolinska Institutet
Collaborating Sponsors:
Stockholm County Council, Karolinska Institutet research foundations, Swedish Society of Medicine, Boston Scientific
Conditions:
Surgical Repair of Middle Compartment Prolapse (Vaginal Vault or Uterine Prolapse) With or Without Cystocele
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
To perform a clinical safety and efficacy assessment of the Uphold LITE system for pelvic organ prolapse in a prospective multicenter, single cohort study.
Eligibility Criteria
Inclusion
- 18 years of age or older and present with primary or recurrent prolapse of the middle vaginal compartment corresponding to stage 2 or higher (according to the Pelvic Organ Prolapse Quantification \[POP-Q\] system)9,
- with or without anterior vaginal wall prolapse, and
- experiences symptoms of vaginal bulging with or without a previous hysterectomy
- being able to provide oral and written informed consent before entering the study.
Exclusion
- previous cancer of any pelvic organ,
- systemic glucocorticoid treatment,
- insulin-treated diabetes,
- an inability to participate in study follow-up or to provide informed consent, or
- the need for any concomitant pelvic surgery.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT01823055
Start Date
January 1 2012
Last Update
April 4 2013
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.