Pelvic Floor Repair System for Prolapse Repair - Full Text View

Sponsored by:	American Medical Systems
Information provided by:	American Medical Systems
ClinicalTrials.gov Identifier:	NCT00638235

Purpose

This is a prospective, single arm, multi-center, post market study, which will be conducted under a common protocol.
The primary objective of the study is to evaluate long-term efficacy of the AMS Pelvic Floor Repair System devices for prolapse repair.
The study population is female subjects > 21 years of age who require surgical reconstruction of their pelvic floor due to prolapse.
The clinical data will be analyzed by comparing post-treatment data with the baseline data, with the subject acting as her own control.The follow-up is two years after the procedure.
Prolapse improvement measured by ICS POP-Q Stage will the primary endpoint of the study. The secondary endpoints include quality of life questionnaires.

Condition	Intervention
Apical Prolapse Posterior Prolapse	Device: AMS Elevate (TM) Apical and Posterior (AMS Pelvic Floor Repair System)

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	A Prospective, Multi-Center Study to Assess the AMS Pelvic Floor Repair System Devices for Prolapse Repair (Phase V)

Resource links provided by NLM:

MedlinePlus related topics: Pelvic Support Problems

U.S. FDA Resources

Further study details as provided by American Medical Systems:

Primary Outcome Measures:

Percent of subjects with an ICS POP-Q Stage of </= Stage I [ Time Frame: at one year post procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of Life (QoL) status [ Time Frame: One year post-procedure ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	April 2008
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
device - implant This is a surgical procedure - device implantation.	Device: AMS Elevate (TM) Apical and Posterior (AMS Pelvic Floor Repair System) AMS Elevate(TM)Apical and Posterior is designed for apical (vault suspension enterocele repair) and posterior (rectocele) prolapse repair. It consists of graft materials and contoured stainless steel needles. The graft material is constructed of either synthetic material (large pore polypropylene mesh) or from xenograft (porcine dermis). This device uses the vaginal approach to pass the needles and place the graft for apical vault suspension and/or posterior prolapse repair.

Arms

Assigned Interventions

device - implant

This is a surgical procedure - device implantation.

Device: AMS Elevate (TM) Apical and Posterior (AMS Pelvic Floor Repair System)

AMS Elevate(TM)Apical and Posterior is designed for apical (vault suspension enterocele repair) and posterior (rectocele) prolapse repair. It consists of graft materials and contoured stainless steel needles. The graft material is constructed of either synthetic material (large pore polypropylene mesh) or from xenograft (porcine dermis). This device uses the vaginal approach to pass the needles and place the graft for apical vault suspension and/or posterior prolapse repair.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Female subjects > 21 years of age who has an at least (>/=) stage II prolapse and require surgical reconstruction.

Exclusion Criteria:

Not a surgical candidate
The Investigator determines the subject is not a candidate for the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00638235

Locations

United States, Idaho
Rosemark Womencare Specialists
808 Pancheri Drive, Idaho Falls, Idaho, United States, 83402
United States, Michigan
Grand Valley Gynecologists, PC
1900 Wealthy Street SE, #330, Grand Rapids, Michigan, United States, 49506
Women's Health Care Specialists, PC
505 Hazen Street Suite 204, Paw Paw, Michigan, United States, 49079
United States, Virginia
Eastern Virginia Medical School
Norfolk, Virginia, United States, 23507

Sponsors and Collaborators

American Medical Systems

Investigators

Principal Investigator:

James C. Lukban, DO

Eastern Virginia Medical School

More Information

Additional Information:

AMS website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	AMS ( Yiming Deng, Ph.D. )
Study ID Numbers:	1004
Study First Received:	February 28, 2008
Last Updated:	September 8, 2008
ClinicalTrials.gov Identifier:	NCT00638235 History of Changes
Health Authority:	United States: Institutional Review Board; Europe: Ethics Committees

Keywords provided by American Medical Systems:

Pelvic floor repair
prolapse
POP-Q test

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Prolapse

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Prolapse

ClinicalTrials.gov processed this record on September 10, 2009