NCT04381728: PREG1

PREvention of Intrauterine Adhesion After Hysteroscopic Surgery With Novel deGradable Film

Completed NA Results posted Last updated 9 November 2021

What this trial tests

NA trial testing Womed Leaf in Intrauterine Adhesion in 23 participants. Completed in 15 March 2021.

Timeline

18 November 2019

Primary endpoint
15 March 2021

15 March 2021

Quick facts

Lead sponsor	Womed
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	23
Start date	18 November 2019
Primary completion	15 March 2021
Estimated completion	15 March 2021
Sites	6 locations across Belgium, France, Netherlands

Drugs / interventions tested

• Womed Leaf

Conditions studied

• Intrauterine Adhesion — all drugs for Intrauterine Adhesion →

Sponsor

Womed

Who can join

Adults 40 to 70, female only, with Intrauterine Adhesion. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Safety (Adverse Events) Primary · 30 days

The number and severity of polymer film related adverse event

Group	Value	95% CI
Womed Leaf	0

Efficacy (Rate of Patient With no IUA) Primary · At second look hysteroscopy between 4 and 8 weeks

Freedom from intrauterine adhesion

Group	Value	95% CI
Womed Leaf	20

Efficacy (Intrauterine Adhesion Severity According to AFS Classification) Primary · At second look hysteroscopy between 4 and 8 weeks

Severity of IUAs according to American Fertility Society (AFS) classification systems of adhesions. Pronostic classification =\> Hysteroscopy score Stade I (mild) =\> 1-4 Stade II (moderate) =\> 5-8 Stade III (severe) =\> 9-12

mild adhesions

Group	Value	95% CI
Womed Leaf	2

moderate adhesions

Group	Value	95% CI
Womed Leaf	1

Efficacy (Intrauterine Adhesion Severity According to ESGE Classification) Primary · At second look hysteroscopy between 4 and 8 weeks

Severity of IUAs according to European Society of Gynecological Endoscopy (ESGE) classification systems of adhesions. I =\> Thin or filmy IUA easily ruptured by HSC sheath alone. Cornual areas normal II =\> Singular dense IUA connecting separate parts of the uterine cavity. Visualization of both tubal ostia possible. Cannot be ruptured by HSC sheath alone IIa =\> Occluding IUA only in the region of the internal cervical os. Upper uterine cavity normal III =\> Multiple dense IUA connecting separate parts of the uterine cavity. Unilateral obliteration of ostial areas of the tubes IV =\> Extensi

Grade II

Group	Value	95% CI
Womed Leaf	1

Grade III

Group	Value	95% CI
Womed Leaf	2

Adverse Events Secondary · 30 days

Number of adverse events (AE) at 30 days

Group	Value	95% CI
Womed Leaf	3

Device Technical Success Secondary · During operation: T=0

Defined as the rate of success of the following 2 steps : insertion and release

Group	Value	95% CI
Womed Leaf	23

Womed Leaf Residuals Secondary · At second look hysteroscopy: 4-8 weeks

Presence of Womed Leaf residuals in the uterus

Group	Value	95% CI
Womed Leaf	0

Womed Leaf Discharge Feedback : Time Interval in Days Between Surgery and Discharge Secondary · At second look hysteroscopy: 4-8 weeks

Uterine film discharge experience as recalled by subject using a survey to be asked to the patient

Group	Value	95% CI
Womed Leaf	6	1 – 15

Device Manipulation Secondary · During intervention: T=0

Device manipulation duration from insertion to withdrawal.

Group	Value	95% CI
Womed Leaf	2	± 0

Womed Leaf Discharge Feedback Questionnaire (Polymer Tolerance Assessed on a Scale From 1 (no Discomfort) to 10 (Extremely Disturbing)) Secondary · At second look hysteroscopy: 4-8 weeks

Uterine film discharge experience as recalled by subject using a survey to be asked to the patient

Group	Value	95% CI
Womed Leaf	1.9	± 1.8

Adverse events — posted to ClinicalTrials.gov

Time frame: 30 days after hysteroscopic myomectomy and device insertion. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Womed Leaf

Serious: 0/23 (0%)

Deaths: 0/23

Other adverse events (3 terms — click to expand)

Reaction	System	Womed Leaf
Bleeding	Surgical and medical procedures	—
renal colic	General disorders	—
Hematoma	Surgical and medical procedures	—

Data from ClinicalTrials.gov NCT04381728 adverse events section.

Sponsor's own description

Intrauterine adhesions (IUA) are the major long-term complication of intrauterine procedures and are associated with pelvic pain, menstrual disorders, obstetrical complication and infertility.

Womed Leaf is a medical device specifically designed for intrauterine use that prevents intra-uterine adhesions. It is a film that acts as a mechanical barrier to keep uterus walls separated during healing. It is then naturally discharged through the cervix and vagina in less than 30 days.

The PREG1 clinical investigation is designed to evaluate Womed Leaf safety under clinical conditions, in women scheduled for a hysteroscopic myomectomy as well as its efficacy.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.