Xenform Postmarket Surveillance Study



Status:Active, not recruiting
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - Any
Updated:3/7/2019
Start Date:February 2014
End Date:December 2019

Use our guide to learn which trials are right for you!

A Prospective, Non-Randomized, Parallel Cohort, Multi-Center Study of Xenform vs. Native Tissue for the Treatment of Women With Anterior/Apical Pelvic Organ Prolapse

To compare transvaginal repair with a biologic graft to traditional native tissue repair in
women surgically treated for anterior and/or apical pelvic organ prolapse.

The primary objective is to evaluate clinical effectiveness of transvaginal repair with
Xenform against traditional native tissue repair in women surgically treated for anterior
and/or apical pelvic organ prolapse. Secondary objectives are to evaluate Xenform-related
complications and subject reported outcomes.

The primary endpoint of the study is to achieve non-inferiority of transvaginal repair with
Xenform over native tissue repair at 36 months as compared to baseline. Success will be based
on a composite of objective and subjective measures.

Additionally, a co-primary endpoint of the study is to achieve non-inferiority of
transvaginal repair with Xenform to native tissue repair for safety by comparing rates of
serious device or serious procedure related complications between baseline and the 36 month
time point.

The secondary endpoints of the study include assessments of complications and subject
reported outcomes.

Inclusion Criteria:

- Subject is female

- Subject is at least 18 years of age

- Subject has pelvic organ prolapse with the leading edge at or beyond the hymen. At or
beyond the hymen is defined as POP-Q scores of Ba≥0 (for prolapse of the anterior
compartment alone) or C≥0 (for prolapse of the apical compartment alone) or C≥-1/2 TVL
and Ba≥0 (for a multi-compartment prolapse that includes the anterior and apical
compartments).

- Subject reports a bothersome bulge they can see or feel per PFDI-20, question 3,
response of 2 or higher (i.e., responses of "somewhat", "moderately", or "quite a
bit")

- Subject or subject's legally authorized representative is willing to provide written
informed consent

- Subject is willing and able to comply with the follow-up regimen

Exclusion Criteria:

- Subject is pregnant or intends to become pregnant during the study

- Subject has an active or chronic systemic infection including any gynecologic
infection, untreated urinary tract infection (UTI) or tissue necrosis

- Subject has history of pelvic organ cancer (e.g. uterine, ovarian, bladder,
colo-rectal or cervical)

- Subject has had prior or is currently undergoing radiation, laser therapy, or
chemotherapy in the pelvic area

- Subject has taken systemic steroids (within the last month), or immunosuppressive or
immunomodulatory treatment (within the last 3 months)

- Subject has systemic connective tissue disease (e.g. scleroderma, systemic lupus
erythematosus (SLE), Marfan syndrome, Ehlers Danlos, collagenosis, polymyositis,
polymyalgia rheumatica)

- Subject has chronic systemic pain that includes the pelvic area or chronic focal pain
that involves the pelvis

- Subject has uncontrolled diabetes mellitus (DM)

- Subject has a known neurologic or medical condition affecting bladder function (e.g.,
multiple sclerosis, spinal cord injury or stroke with residual neurologic deficit)

- Subject is seeking obliterative vaginal surgery as treatment for pelvic organ prolapse
(colpocleisis)

- Subject is not able to conform to the modified dorsal lithotomy position

- Subject is currently participating in or plans to participate in another device or
drug study during this study

- Subject has a known sensitivity to any Xenform component

- Subject has had previous prolapse repair with mesh in the target compartment

- Subject is planning to undergo a concomitant prolapse repair with use of mesh in the
non-target compartment
We found this trial at
25
sites
Kalamazoo, Michigan 49009
1833
mi
from 91732
Kalamazoo, MI
Click here to add this to my saved trials
305 1st Avenue # Dazian 7
New York, New York 10003
(212) 420-2806
Beth Israel Med Ctr The physicians and staff of Mount Sinai Beth Israel's Heart Institute...
2433
mi
from 91732
New York, NY
Click here to add this to my saved trials
Atlanta, Georgia 30322
1922
mi
from 91732
Atlanta, GA
Click here to add this to my saved trials
1120 15th Street
Augusta, Georgia 30912
(706) 721-0211
Georgia Regents University Georgia Regents University, home of the Medical College of Georgia, is one...
2059
mi
from 91732
Augusta, GA
Click here to add this to my saved trials
Buffalo, New York 14215
2184
mi
from 91732
Buffalo, NY
Click here to add this to my saved trials
Cambridge, Massachusetts 02138
2575
mi
from 91732
Cambridge, MA
Click here to add this to my saved trials
Canton, Georgia 30114
1907
mi
from 91732
Canton, GA
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
(919) 962-2211
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
2194
mi
from 91732
Chapel Hill, NC
Click here to add this to my saved trials
27121 174th Place Southeast
Covington, Washington 98042
942
mi
from 91732
Covington, WA
Click here to add this to my saved trials
Crowley, Louisiana 70526
?
mi
from 91732
Crowley, LA
Click here to add this to my saved trials
1223
mi
from 91732
Dallas, TX
Click here to add this to my saved trials
Dresden, Ohio 43821
2013
mi
from 91732
Dresden, OH
Click here to add this to my saved trials
Franklin, Tennessee 37067
1759
mi
from 91732
Franklin, TN
Click here to add this to my saved trials
Gastonia, North Carolina 28054
2082
mi
from 91732
Gastonia, NC
Click here to add this to my saved trials
Glen Burnie, Maryland 21061
2301
mi
from 91732
Glen Burnie, MD
Click here to add this to my saved trials
Greenville, South Carolina 29615
2018
mi
from 91732
Greenville, SC
Click here to add this to my saved trials
Houston, Texas 77027
1353
mi
from 91732
Houston, TX
Click here to add this to my saved trials
Irving, Texas 75062
1213
mi
from 91732
Irving, TX
Click here to add this to my saved trials
New York, New York 10016
2434
mi
from 91732
New York, NY
Click here to add this to my saved trials
101 The City Drive South
Orange, California 92868
714-456-7890
University of California, Irvine Medical Center We are UC Irvine Health. We are a devoted...
21
mi
from 91732
Orange, CA
Click here to add this to my saved trials
Owings Mills, Maryland 21117
2292
mi
from 91732
Owings Mills, MD
Click here to add this to my saved trials
Skokie, Illinois 60077
1724
mi
from 91732
Skokie, IL
Click here to add this to my saved trials
Voorhees, New Jersey 08043
2408
mi
from 91732
Voorhees, NJ
Click here to add this to my saved trials
West Columbia, South Carolina 29169
2103
mi
from 91732
West Columbia, SC
Click here to add this to my saved trials
Winston-Salem, North Carolina 27103
2122
mi
from 91732
Winston-Salem, NC
Click here to add this to my saved trials