Trial Outcomes & Findings for PREvention of Intrauterine Adhesion After Hysteroscopic Surgery With Novel deGradable Film (NCT NCT04381728)

NCT ID: NCT04381728

Last Updated: 2021-11-09

Results Overview

The number and severity of polymer film related adverse event

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 23 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2021-11-09

Participant Flow

Six centers in France, Belgium and the Netherlands participated in the trial. Between November 2019 and January 2021, 23 patients were enrolled into the study.

Participant milestones

Measure	Womed Leaf At the end of the hysteroscopic myomectomy, Womed Leaf was delivered in the uterus thanks to a 5mm diameter, flexible inserter. Then an endovaginal ultrasound was performed to assess the positioning of the uterine film. Another ultrasound was performed at 2 hours, prior to patient discharge in order to record images of the uterine film deployment. A second look hysteroscopy was performed at 4-8 weeks to evaluate the presence of intrauterine adhesion.
Overall Study STARTED	23
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Womed Leaf n=23 Participants At the end of the hysteroscopic myomectomy, Womed Leaf was delivered in the uterus thanks to a 5mm diameter, flexible inserter. Then an endovaginal ultrasound was performed to assess the positioning of the uterine film. Another ultrasound was performed at 2 hours, prior to patient discharge in order to record images of the uterine film deployment. A second look hysteroscopy was performed at 4-8 weeks to evaluate the presence of intrauterine adhesion.
Age, Continuous	47 years STANDARD_DEVIATION 6 • n=23 Participants
Sex: Female, Male Female	23 Participants n=23 Participants
Sex: Female, Male Male	0 Participants n=23 Participants
Region of Enrollment Netherlands	7 participants n=23 Participants
Region of Enrollment Belgium	4 participants n=23 Participants
Region of Enrollment France	12 participants n=23 Participants
Myoma type (FIGO classification) FIGO type 0 (pedunculated intracavitary)	4 Participants n=23 Participants
Myoma type (FIGO classification) FIGO type 1 (< 50% intramural)	10 Participants n=23 Participants
Myoma type (FIGO classification) FIGO type 2 (> 50% intramural)	9 Participants n=23 Participants
Mean number of tumor resected	1.3 tumors resected STANDARD_DEVIATION 0.9 • n=23 Participants

PRIMARY outcome

Timeframe: 30 days

The number and severity of polymer film related adverse event

Outcome measures

Measure

Womed Leaf n=23 Participants At the end of the hysteroscopic myomectomy, Womed Leaf was delivered in the uterus thanks to a 5mm diameter, flexible inserter. Then an endovaginal ultrasound was performed to assess the positioning of the uterine film. Another ultrasound was performed at 2 hours, prior to patient discharge in order to record images of the uterine film deployment. A second look hysteroscopy was performed at 4-8 weeks to evaluate the presence of intrauterine adhesion.

Safety (Adverse Events)

0 device related adverse event

PRIMARY outcome

Timeframe: At second look hysteroscopy between 4 and 8 weeks

Freedom from intrauterine adhesion

Outcome measures

Measure

Womed Leaf n=23 Participants At the end of the hysteroscopic myomectomy, Womed Leaf was delivered in the uterus thanks to a 5mm diameter, flexible inserter. Then an endovaginal ultrasound was performed to assess the positioning of the uterine film. Another ultrasound was performed at 2 hours, prior to patient discharge in order to record images of the uterine film deployment. A second look hysteroscopy was performed at 4-8 weeks to evaluate the presence of intrauterine adhesion.

Efficacy (Rate of Patient With no IUA)

20 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Womed Leaf n=23 Participants At the end of the hysteroscopic myomectomy, Womed Leaf was delivered in the uterus thanks to a 5mm diameter, flexible inserter. Then an endovaginal ultrasound was performed to assess the positioning of the uterine film. Another ultrasound was performed at 2 hours, prior to patient discharge in order to record images of the uterine film deployment. A second look hysteroscopy was performed at 4-8 weeks to evaluate the presence of intrauterine adhesion.
Efficacy (Intrauterine Adhesion Severity According to AFS Classification) mild adhesions	2 Participants
Efficacy (Intrauterine Adhesion Severity According to AFS Classification) moderate adhesions	1 Participants

PRIMARY outcome

Timeframe: 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 => Extensive dense IUA with (partial) occlusion of the uterine cavity. Both tubal ostial areas (partially) occluded Va => Extensive endometrial scarring and fibrosis in combination with grade I or grade II IUA with amenorrhea or pronounced hypomenorrhea Vb => Extensive endometrial scarring and fibrosis in combination with grade III or grade IV IUA with amenorrhea

Outcome measures

Measure	Womed Leaf n=23 Participants At the end of the hysteroscopic myomectomy, Womed Leaf was delivered in the uterus thanks to a 5mm diameter, flexible inserter. Then an endovaginal ultrasound was performed to assess the positioning of the uterine film. Another ultrasound was performed at 2 hours, prior to patient discharge in order to record images of the uterine film deployment. A second look hysteroscopy was performed at 4-8 weeks to evaluate the presence of intrauterine adhesion.
Efficacy (Intrauterine Adhesion Severity According to ESGE Classification) Grade II	1 Participants
Efficacy (Intrauterine Adhesion Severity According to ESGE Classification) Grade III	2 Participants

SECONDARY outcome

Timeframe: 30 days

Number of adverse events (AE) at 30 days

Outcome measures

Measure

Womed Leaf n=23 Participants At the end of the hysteroscopic myomectomy, Womed Leaf was delivered in the uterus thanks to a 5mm diameter, flexible inserter. Then an endovaginal ultrasound was performed to assess the positioning of the uterine film. Another ultrasound was performed at 2 hours, prior to patient discharge in order to record images of the uterine film deployment. A second look hysteroscopy was performed at 4-8 weeks to evaluate the presence of intrauterine adhesion.

Adverse Events

3 adverse events

SECONDARY outcome

Timeframe: During operation: T=0

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

Outcome measures

Measure

Womed Leaf n=23 Participants At the end of the hysteroscopic myomectomy, Womed Leaf was delivered in the uterus thanks to a 5mm diameter, flexible inserter. Then an endovaginal ultrasound was performed to assess the positioning of the uterine film. Another ultrasound was performed at 2 hours, prior to patient discharge in order to record images of the uterine film deployment. A second look hysteroscopy was performed at 4-8 weeks to evaluate the presence of intrauterine adhesion.

Device Technical Success

23 Participants

SECONDARY outcome

Timeframe: At second look hysteroscopy: 4-8 weeks

Presence of Womed Leaf residuals in the uterus

Outcome measures

Measure

Womed Leaf n=23 Participants At the end of the hysteroscopic myomectomy, Womed Leaf was delivered in the uterus thanks to a 5mm diameter, flexible inserter. Then an endovaginal ultrasound was performed to assess the positioning of the uterine film. Another ultrasound was performed at 2 hours, prior to patient discharge in order to record images of the uterine film deployment. A second look hysteroscopy was performed at 4-8 weeks to evaluate the presence of intrauterine adhesion.

Womed Leaf Residuals

0 Participants

SECONDARY outcome

Timeframe: At second look hysteroscopy: 4-8 weeks

Population: 10 patients did not notice the discharge of the device

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

Outcome measures

Measure

Womed Leaf n=13 Participants At the end of the hysteroscopic myomectomy, Womed Leaf was delivered in the uterus thanks to a 5mm diameter, flexible inserter. Then an endovaginal ultrasound was performed to assess the positioning of the uterine film. Another ultrasound was performed at 2 hours, prior to patient discharge in order to record images of the uterine film deployment. A second look hysteroscopy was performed at 4-8 weeks to evaluate the presence of intrauterine adhesion.

Womed Leaf Discharge Feedback : Time Interval in Days Between Surgery and Discharge

6 days Interval 1.0 to 15.0

SECONDARY outcome

Timeframe: During intervention: T=0

Device manipulation duration from insertion to withdrawal.

Outcome measures

Measure

Womed Leaf n=23 Participants At the end of the hysteroscopic myomectomy, Womed Leaf was delivered in the uterus thanks to a 5mm diameter, flexible inserter. Then an endovaginal ultrasound was performed to assess the positioning of the uterine film. Another ultrasound was performed at 2 hours, prior to patient discharge in order to record images of the uterine film deployment. A second look hysteroscopy was performed at 4-8 weeks to evaluate the presence of intrauterine adhesion.

Device Manipulation

2 minutes Standard Deviation 0

SECONDARY outcome

Timeframe: At second look hysteroscopy: 4-8 weeks

Population: 10 patients did not notice the discharge of the device

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

Outcome measures

Measure

Womed Leaf n=13 Participants At the end of the hysteroscopic myomectomy, Womed Leaf was delivered in the uterus thanks to a 5mm diameter, flexible inserter. Then an endovaginal ultrasound was performed to assess the positioning of the uterine film. Another ultrasound was performed at 2 hours, prior to patient discharge in order to record images of the uterine film deployment. A second look hysteroscopy was performed at 4-8 weeks to evaluate the presence of intrauterine adhesion.

Womed Leaf Discharge Feedback Questionnaire (Polymer Tolerance Assessed on a Scale From 1 (no Discomfort) to 10 (Extremely Disturbing))

1.9 scale from 1 (no discomfort) to 10 Standard Deviation 1.8

Adverse Events

Womed Leaf

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Womed Leaf n=23 participants at risk At the end of the hysteroscopic myomectomy, Womed Leaf was delivered in the uterus thanks to a 5mm diameter, flexible inserter. Then an endovaginal ultrasound was performed to assess the positioning of the uterine film. Another ultrasound was performed at 2 hours, prior to patient discharge in order to record images of the uterine film deployment. A second look hysteroscopy was performed at 4-8 weeks to evaluate the presence of intrauterine adhesion.
Surgical and medical procedures Bleeding	4.3% 1/23 • 30 days after hysteroscopic myomectomy and device insertion
General disorders renal colic	4.3% 1/23 • 30 days after hysteroscopic myomectomy and device insertion
Surgical and medical procedures Hematoma	4.3% 1/23 • 30 days after hysteroscopic myomectomy and device insertion

Additional Information

Pauline Chirouze

WOMED

Phone: 0785225561

Email: pauline@womedtech.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place