An interventional study of Womed Leaf in Intrauterine Adhesion, sponsored by Womed. Completed at 6 sites in 3 countries. Open to female participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-11-09.
Sponsored by Womed · Not applicable, Interventional, and Prevention
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.
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.
241 studies on the registry are indexed under Tissue Adhesions; 29 are open to participants now.
This study's enrollment of 23 is below the median of 60 across 184 interventional studies indexed under Tissue Adhesions.
Browse Tissue Adhesions studies →Womed is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Pre-operative exclusion criteria:
Per-operative exclusion criteria:
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.
Device: Womed Leaf
Womed Leaf uterine film will be inserted immediately after the myomectomy, following per-operative hysterometry.
Safety (Adverse Events)
The number and severity of polymer film related adverse event
Time frame: 30 days
Efficacy (Rate of Patient With no IUA)
Freedom from intrauterine adhesion
Time frame: 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
Time frame: 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
Time frame: At second look hysteroscopy between 4 and 8 weeks
Adverse Events
Number of adverse events (AE) at 30 days
Time frame: 30 days
Device Technical Success
Defined as the rate of success of the following 2 steps : insertion and release
Time frame: During operation: T=0
Womed Leaf Residuals
Presence of Womed Leaf residuals in the uterus
Time frame: 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
Time frame: At second look hysteroscopy: 4-8 weeks
Device Manipulation
Device manipulation duration from insertion to withdrawal.
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))
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
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.
| Milestone | Womed Leaf |
|---|---|
| Started | 23 |
| Completed | 23 |
| Not completed | 0 |
The number and severity of polymer film related adverse event
| device related adverse event | Womed Leaf |
|---|---|
| Safety (Adverse Events) | 0 |
Freedom from intrauterine adhesion
| Participants | Womed Leaf |
|---|---|
| Efficacy (Rate of Patient With no IUA) | 20 |
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
| Participants | Womed Leaf |
|---|---|
| mild adhesions | 2 |
| moderate adhesions | 1 |
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
| Participants | Womed Leaf |
|---|---|
| Grade II | 1 |
| Grade III | 2 |
Number of adverse events (AE) at 30 days
| adverse events | Womed Leaf |
|---|---|
| Adverse Events | 3 |
Defined as the rate of success of the following 2 steps : insertion and release
| Participants | Womed Leaf |
|---|---|
| Device Technical Success | 23 |
Presence of Womed Leaf residuals in the uterus
| Participants | Womed Leaf |
|---|---|
| Womed Leaf Residuals | 0 |
Uterine film discharge experience as recalled by subject using a survey to be asked to the patient
| days | Womed Leaf |
|---|---|
| Womed Leaf Discharge Feedback : Time Interval in Days Between Surgery and Discharge | 6 (1 to 15) |
Device manipulation duration from insertion to withdrawal.
| minutes | Womed Leaf |
|---|---|
| Device Manipulation | 2 ± 0 |
Uterine film discharge experience as recalled by subject using a survey to be asked to the patient
| scale from 1 (no discomfort) to 10 | Womed Leaf |
|---|---|
| Womed Leaf Discharge Feedback Questionnaire (Polymer Tolerance Assessed on a Scale From 1 (no Discomfort) to 10 (Extremely Disturbing)) | 1.9 ± 1.8 |
Collected over 30 days after hysteroscopic myomectomy and device insertion. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Womed Leaf | 0/23 (0%) | 0/23 (0%) | 3/23 (13%) |
| Event | Womed Leaf |
|---|---|
| BleedingSurgical and medical procedures | 1/23 |
| renal colicGeneral disorders | 1/23 |
| HematomaSurgical and medical procedures | 1/23 |
| Age, Continuous(years) | Womed Leaf |
|---|---|
| Mean | 47 ± 6 |
| Sex: Female, Male(Participants) | Womed Leaf |
|---|---|
| Female | 23 |
| Male | 0 |
| Race and Ethnicity Not Collected(Participants) | Womed Leaf |
|---|
| Region of Enrollment(participants) | Womed Leaf |
|---|---|
| Netherlands | 7 |
| Belgium | 4 |
| France | 12 |
| Myoma type (FIGO classification)(Participants) | Womed Leaf |
|---|---|
| FIGO type 0 (pedunculated intracavitary) | 4 |
| FIGO type 1 (< 50% intramural) | 10 |
| FIGO type 2 (> 50% intramural) | 9 |
| Mean number of tumor resected(tumors resected) | Womed Leaf |
|---|---|
| Mean | 1.3 ± 0.9 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — No sharing of individual participant data is planed
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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