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PREvention of Intrauterine Adhesion After Hysteroscopic Surgery With Novel deGradable Film (PREG1)

Primary Purpose

Intrauterine Adhesion

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Womed Leaf
Sponsored by
Womed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intrauterine Adhesion focused on measuring myomectomy, Intrauterine adhesion, hysteroscopy

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women ≥ 40 years AND no childbearing wish, OR history of permanent sterilization;
  • Subject scheduled for hysteroscopic myomectomy for one or more myoma(s) where one myoma is at least 10 mm in size (≥10mm) as estimated by pre-operative ultrasound measurement of the largest diameter,
  • Hysterometry prior to device insertion ≥ 6cm and ≤ 9cm.
  • Subjects who are willing to provide a written informed consent as approved by the applicable Ethics Committee prior to participating in this clinical investigation.
  • Subjects who can comply with the study follow-up or other study requirements

Exclusion Criteria:

Pre-operative exclusion criteria:

  • Current pregnancy
  • Abnormal uterine cavity according to ESHRE classification I to VI, such as unicornis, bicornis, septate, duplex
  • Known or suspected endometrial hyperplasia
  • Medical history of cervical or endometrial cancer
  • Active pelvic infection or medical history of pelvic peritonitis
  • Intrauterine device in situ
  • Known contraindication or hypersensitivity to PEO or PLA, and to medications such as aspirin….
  • Concurrent medical condition with a life expectancy of less than 12 months
  • Full endometrial ablation

Per-operative exclusion criteria:

  • Adenomyosis
  • Inflammation (endometritis)
  • Abnormal uterine cavity
  • Hysterometry < 6cm or >9cm
  • Any complication during the intervention that is deemed to potentially interfere with the objective of the study by the investigator

Sites / Locations

  • UZ Gent
  • CHU Nîmes
  • CHU Bicêtre (APHP)
  • Bergman Clinics
  • Zaans Medical Center
  • Isala Zwolle

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Womed Leaf

Arm Description

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

Outcomes

Primary Outcome Measures

Safety (Adverse Events)
The number and severity of polymer film related adverse event
Efficacy (Rate of Patient With no IUA)
Freedom from intrauterine adhesion
Efficacy (Intrauterine Adhesion Severity According to AFS Classification)
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
Efficacy (Intrauterine Adhesion Severity According to ESGE Classification)
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

Secondary Outcome Measures

Adverse Events
Number of adverse events (AE) at 30 days
Device Technical Success
Defined as the rate of success of the following 2 steps : insertion and release
Womed Leaf Residuals
Presence of Womed Leaf residuals in the uterus
Womed Leaf Discharge Feedback : Time Interval in Days Between Surgery and Discharge
Uterine film discharge experience as recalled by subject using a survey to be asked to the patient
Device Manipulation
Device manipulation duration from insertion to withdrawal.
Womed Leaf Discharge Feedback Questionnaire (Polymer Tolerance Assessed on a Scale From 1 (no Discomfort) to 10 (Extremely Disturbing))
Uterine film discharge experience as recalled by subject using a survey to be asked to the patient

Full Information

First Posted
April 28, 2020
Last Updated
November 8, 2021
Sponsor
Womed
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1. Study Identification

Unique Protocol Identification Number
NCT04381728
Brief Title
PREvention of Intrauterine Adhesion After Hysteroscopic Surgery With Novel deGradable Film
Acronym
PREG1
Official Title
PREvention of Intrauterine Adhesion After Hysteroscopic Surgery With Novel deGradable Film
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
November 18, 2019 (Actual)
Primary Completion Date
March 15, 2021 (Actual)
Study Completion Date
March 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Womed

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
Intrauterine adhesions (IUA) are defined as "fibrous strings at opposing walls of the uterus and/or cervix leading to partial or complete obliteration of the cavity". IUAs are the major long-term complication of intrauterine procedures and are associated with pelvic pain, menstrual disorders, obstetrical complications and infertility. Womed Leaf™ is a sterile, degradable polymer film specifically design for intrauterine use. It is inserter in the uterus like an intrauterine device. Once released it will self-deploy into the uterine cavity to form a mechanical barrier keeping uterus walls separated during healing, for several days, thus preventing the formation or recurrence of intrauterine adhesions. It is degraded and discharged naturally through the cervix and vagina in less than 30 days. The PREG1 clinical investigation is a prospective multicenter, single arm study, designed to evaluate Womed Leaf safety under clinical conditions, in women scheduled for a hysteroscopic myomectomy as well as its efficacy in preventing IUA at second look hysteroscopy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intrauterine Adhesion
Keywords
myomectomy, Intrauterine adhesion, hysteroscopy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Womed Leaf
Arm Type
Experimental
Arm Description
At the end of the hysteroscopic myomectomy, Womed Leaf is delivered in the uterus thanks to a 5mm diameter, flexible inserter. Then an endovaginal ultrasound will be performed to assess the positioning of the uterine film. Another ultrasound will be performed at 2 hours, prior to patient discharge in order to record images of the uterine film deployment. A second look hysteroscopy will performed at 4-8 weeks to evaluate the presence of intrauterine adhesion.
Intervention Type
Device
Intervention Name(s)
Womed Leaf
Intervention Description
Womed Leaf uterine film will be inserted immediately after the myomectomy, following per-operative hysterometry.
Primary Outcome Measure Information:
Title
Safety (Adverse Events)
Description
The number and severity of polymer film related adverse event
Time Frame
30 days
Title
Efficacy (Rate of Patient With no IUA)
Description
Freedom from intrauterine adhesion
Time Frame
At second look hysteroscopy between 4 and 8 weeks
Title
Efficacy (Intrauterine Adhesion Severity According to AFS Classification)
Description
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
Time Frame
At second look hysteroscopy between 4 and 8 weeks
Title
Efficacy (Intrauterine Adhesion Severity According to ESGE Classification)
Description
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
Time Frame
At second look hysteroscopy between 4 and 8 weeks
Secondary Outcome Measure Information:
Title
Adverse Events
Description
Number of adverse events (AE) at 30 days
Time Frame
30 days
Title
Device Technical Success
Description
Defined as the rate of success of the following 2 steps : insertion and release
Time Frame
During operation: T=0
Title
Womed Leaf Residuals
Description
Presence of Womed Leaf residuals in the uterus
Time Frame
At second look hysteroscopy: 4-8 weeks
Title
Womed Leaf Discharge Feedback : Time Interval in Days Between Surgery and Discharge
Description
Uterine film discharge experience as recalled by subject using a survey to be asked to the patient
Time Frame
At second look hysteroscopy: 4-8 weeks
Title
Device Manipulation
Description
Device manipulation duration from insertion to withdrawal.
Time Frame
During intervention: T=0
Title
Womed Leaf Discharge Feedback Questionnaire (Polymer Tolerance Assessed on a Scale From 1 (no Discomfort) to 10 (Extremely Disturbing))
Description
Uterine film discharge experience as recalled by subject using a survey to be asked to the patient
Time Frame
At second look hysteroscopy: 4-8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women ≥ 40 years AND no childbearing wish, OR history of permanent sterilization; Subject scheduled for hysteroscopic myomectomy for one or more myoma(s) where one myoma is at least 10 mm in size (≥10mm) as estimated by pre-operative ultrasound measurement of the largest diameter, Hysterometry prior to device insertion ≥ 6cm and ≤ 9cm. Subjects who are willing to provide a written informed consent as approved by the applicable Ethics Committee prior to participating in this clinical investigation. Subjects who can comply with the study follow-up or other study requirements Exclusion Criteria: Pre-operative exclusion criteria: Current pregnancy Abnormal uterine cavity according to ESHRE classification I to VI, such as unicornis, bicornis, septate, duplex Known or suspected endometrial hyperplasia Medical history of cervical or endometrial cancer Active pelvic infection or medical history of pelvic peritonitis Intrauterine device in situ Known contraindication or hypersensitivity to PEO or PLA, and to medications such as aspirin…. Concurrent medical condition with a life expectancy of less than 12 months Full endometrial ablation Per-operative exclusion criteria: Adenomyosis Inflammation (endometritis) Abnormal uterine cavity Hysterometry < 6cm or >9cm Any complication during the intervention that is deemed to potentially interfere with the objective of the study by the investigator
Facility Information:
Facility Name
UZ Gent
City
Gent
Country
Belgium
Facility Name
CHU Nîmes
City
Nîmes
Country
France
Facility Name
CHU Bicêtre (APHP)
City
Paris
Country
France
Facility Name
Bergman Clinics
City
Amsterdam
Country
Netherlands
Facility Name
Zaans Medical Center
City
Amsterdam
Country
Netherlands
Facility Name
Isala Zwolle
City
Zwolle
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No sharing of individual participant data is planed
Citations:
PubMed Identifier
34343712
Citation
Weyers S, Capmas P, Huberlant S, Dijkstra JR, Hooker AB, Hamerlynck T, Debras E, De Tayrac R, Thurkow AL, Fernandez H. Safety and Efficacy of a Novel Barrier Film to Prevent Intrauterine Adhesion Formation after Hysteroscopic Myomectomy: The PREG1 Clinical Trial. J Minim Invasive Gynecol. 2022 Jan;29(1):151-157. doi: 10.1016/j.jmig.2021.07.017. Epub 2021 Jul 31.
Results Reference
derived

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PREvention of Intrauterine Adhesion After Hysteroscopic Surgery With Novel deGradable Film

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