Intrauterine AdhesionPREG1NCT04381728
PREvention of Intrauterine Adhesion After Hysteroscopic Surgery With Novel deGradable Film
A study testing Womed Leaf in people with Intrauterine Adhesion, run by Womed at 6 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women only
- Conditions the study is for
- Intrauterine Adhesion
- What is being tested?
- Womed Leaf
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 18 Nov 2019to 15 Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Netherlands3 sites
Bergman Clinics
Amsterdam
Zaans Medical Center
Amsterdam
Isala Zwolle
Zwolle
About this study
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.
Read the 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.
- Conditions
- Intrauterine Adhesion
- Being tested
- Womed Leaf
- Keywords
- myomectomy, Intrauterine adhesion, hysteroscopy
- Medical subject headings
- Gynatresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Womed LeafDevice
Womed Leaf uterine film will be inserted immediately after the myomectomy, following per-operative hysterometry.
| Study group | Role | What they receive |
|---|---|---|
| Womed Leaf | Experimental | 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. Receives: Device: Womed Leaf |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (Adverse Events)
The number and severity of polymer film related adverse event
Measured: 30 days
Efficacy (Rate of Patient With no IUA)
Freedom from intrauterine adhesion
Measured: At second look hysteroscopy between 4 and 8 weeks
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
Measured: At second look hysteroscopy between 4 and 8 weeks
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
Measured: At second look hysteroscopy between 4 and 8 weeks
Secondary outcomes (6)
Adverse Events
Number of adverse events (AE) at 30 days
Measured: 30 days
Device Technical Success
Defined as the rate of success of the following 2 steps : insertion and release
Measured: During operation: T=0
Womed Leaf Residuals
Presence of Womed Leaf residuals in the uterus
Measured: At second look hysteroscopy: 4-8 weeks
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
Measured: At second look hysteroscopy: 4-8 weeks
Device Manipulation
Device manipulation duration from insertion to withdrawal.
Measured: During intervention: T=0
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
Measured: At second look hysteroscopy: 4-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start18 Nov 2019
- Primary completion15 Mar 2021
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intrauterine AdhesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Womed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04381728
- Sponsor's protocol ID
- PREG1
- Acronym
- PREG1
- Status last verified
- Nov 2021
- First submitted
- 28 Apr 2020
- Last updated
- 9 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No sharing of individual participant data is planed
Publications
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.
PubMed 34343712
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREvention of Intrauterine Adhesion After Hysteroscopic Surgery With Novel deGradable Film
- ClinicalTrials.gov ID
- NCT04381728
- Acronym / sponsor ID
- PREG1 / PREG1
- Conditions
- Intrauterine Adhesion
- Keywords
- myomectomy, Intrauterine adhesion, hysteroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- WomedIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 11 May 2020 (actual)
- Results
- Posted 9 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Womed Leaf | Experimental | Device: Womed LeafAt 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Womed LeafWomed Leaf uterine film will be inserted immediately after the myomectomy, following per-operative hysterometry. | Device | Womed Leaf |
Primary outcome
Safety (Adverse Events)
Time frame: 30 days
The number and severity of polymer film related adverse event
Efficacy (Rate of Patient With no IUA)
Time frame: At second look hysteroscopy between 4 and 8 weeks
Freedom from intrauterine adhesion
Efficacy (Intrauterine Adhesion Severity According to AFS Classification)
Time frame: 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
Efficacy (Intrauterine Adhesion Severity According to ESGE Classification)
Time frame: 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
6 secondary outcomes
Adverse Events
Time frame: 30 days
Device Technical Success
Time frame: During operation: T=0
Womed Leaf Residuals
Time frame: At second look hysteroscopy: 4-8 weeks
Womed Leaf Discharge Feedback : Time Interval in Days Between Surgery and Discharge
Time frame: At second look hysteroscopy: 4-8 weeks
Device Manipulation
Time frame: During intervention: T=0
Womed Leaf Discharge Feedback Questionnaire (Polymer Tolerance Assessed on a Scale From 1 (no Discomfort) to 10 (Extremely Disturbing))
Time frame: At second look hysteroscopy: 4-8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34343712Weyers 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.
- Individual participant dataSharing planned: No. No sharing of individual participant data is planed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Womed Leaf in people with Intrauterine Adhesion, run by Womed at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Netherlands, France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (Adverse Events) (time frame: 30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04381728, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2021.