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|
| General |
| Study Status |
Study Pending |
Application Number /
Requirement Number |
P240015 / PAS001 |
| Date Original Protocol Accepted |
09/09/2025
|
| Date Current Protocol Accepted |
09/09/2025
|
| Study Name |
Post-Approval Study
|
| Device Name |
Womed Leaf Resorbable Adhesion Barrier
|
| Clinical Trial Number(s) |
NCT04381728 NCT04963179
|
| General Study Protocol Parameters |
| Study Design |
Randomized Clinical Trial
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
Concurrent Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The objective is to evaluate the long-term safety of the Womed Leaf device. This is a continued follow-up of the patients enrolled under the PREG2 pivotal trial.
|
| Study Population |
The PAS population is the PREG2 trial cohort which included women with symptomatic (e.g., amenorrhea, infertility, recurrent pregnancy loss) moderate or severe intrauterine adhesions (AFS score >/= 5) confirmed by hysteroscopy, scheduled for hysteroscopic adhesiolysis.
|
| Sample Size |
160 participants
|
| Key Study Endpoints |
Primary endpoint: The primary endpoint is the live birth rate. Live birth rate must be reported at one, two, and three years follow-up. Live birth is defined as the delivery of a live born infant who breathes or shows any other evidence of life, such as heartbeat or movement, and refers to an individual newborn.
Secondary endpoints:
1. Clinical pregnancy rates, whether spontaneous or assisted (ovulation induction, intrauterine insemination; in vitro fertilization (IVF) and embryo transfer (ET)), at one, two, and three years, where clinical pregnancy is defined as the presence of fetal sac or heartbeat confirmed by ultrasound.
2. Average time to first pregnancy (i.e., time between the second look hysteroscopy and estimated date of conception) at one, two, and three years.
3. Pregnancy rate leading to a live birth at one, two, and three years, where pregnancy rate is defined as the presence of fetal sac or heartbeat by ultrasound or a positive urinary test or blood test leading to a live birth.
4. Pregnancy related events at one, two, and three years:
a. Miscarriage (intrauterine pregnancy loss before 20 weeks gestation)
b. Ectopic pregnancy (defined as pregnancy outside of the endometrial cavity, diagnosed by ultrasound, surgical visualization, or histopathology)
c. Retained products of conception
d. Termination of pregnancy
e. Intrauterine growth restriction
f. Premature rupture of the membranes
g. Placenta previa
h. Premature delivery (defined as a delivery before the 37th week of pregnancy)
i. Uterine rupture
j. Postpartum hemorrhage
k. Placenta accreta spectrum (accreta, increta, percreta)
l. Intrauterine fetal demise defined as the death of a fetus of at least 20 weeks gestational age
m. Other
5. Reintervention rate (repeat adhesiolysis) after second look hysteroscopy up to one year following the index procedure.
6. Average number of adhesiolysis procedures per patient after second look hysteroscopy up to one year following the index procedure.
7. Improvement in menstrual pattern at one, two, and three years compared to baseline. Menstrual pattern is considered improved if menses is resumed for amenorrheic patients or if hypomenorrhea (scant spotting or light period) patients experience an increased duration or increased volume of periods compared to that previously reported.
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| Follow-up Visits and Length of Follow-up |
3 years
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