- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01823055
Safety and Efficacy of a Transvaginal Suture Capturing Mesh Device
April 2, 2013 updated by: Daniel Altman, Karolinska Institutet
Safety and Efficacy of a Transvaginal Suture Capturing Mesh Device: The Nordic Uphold LITE Trial
To perform a clinical safety and efficacy assessment of the Uphold LITE system for pelvic organ prolapse in a prospective multicenter, single cohort study.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
214
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Surgery
Transvaginal suture capturing mesh device
|
The Uphold™ LITE vaginal support system is an intra-vaginal approach to apical and anterior vaginal wall prolapse repair that utilizes a suture capturing device to place the mesh.
After primary dissection the suturing device is used to pull the mesh through the sacrospinous ligament, medial to the ischial spine.
An anterior colporraphy was allowed following the Uphold™ LITE procedure at the discretion of the surgeon if deemed necessary.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immediate and delayed complications related to the surgical procedure
Time Frame: 1 year
|
Serious surgical complications are categorised as any surgical event which is potentially life-threatening, internal organ perforation (or other injury), bleeding in excess of 1000 mL or adverse events, related to the surgical procedure, during follow-up which requires re-hospitalisation.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pelvic Organ Prolapse Quantification system
Time Frame: 1 year
|
The secondary efficacy outcome is a composite of objective and subjective measures including POP-Q stage 0 or 1 of the upper vaginal segment (i.e., point C/D, which represents the most distal point of the vaginal apex in relation to the total vaginal length) and a negative response to the question, "Do you experience a feeling of bulging or protrusion in the vaginal area?" (question 16 on the UDI).
The secondary outcome measures further include the individual components of the composite end point, other POP-Q measurements and patient-reported urogenital distress.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
March 28, 2013
First Submitted That Met QC Criteria
April 2, 2013
First Posted (Estimate)
April 4, 2013
Study Record Updates
Last Update Posted (Estimate)
April 4, 2013
Last Update Submitted That Met QC Criteria
April 2, 2013
Last Verified
March 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Karolinska Institutet
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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