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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Womed Leaf | Device | Womed Leaf uterine film will be inserted immediately after the myomectomy, following per-operative hysterometry. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety (Adverse Events) | The number and severity of polymer film related adverse event | 30 days |
| Efficacy (Rate of Patient With no IUA) | Freedom from intrauterine adhesion | 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 | 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 | At second look hysteroscopy between 4 and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Number of adverse events (AE) at 30 days | 30 days |
| Device Technical Success | Defined as the rate of success of the following 2 steps : insertion and release |
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Inclusion Criteria:
Exclusion Criteria:
Pre-operative exclusion criteria:
Per-operative exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Gent | Ghent | Belgium | ||||
| CHU Nîmes |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34343712 | Derived | 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. |
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No sharing of individual participant data is planed
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety (Adverse Events) | The number and severity of polymer film related adverse event | Posted | Number | device related adverse event | 30 days |
|
|
30 days after hysteroscopic myomectomy and device insertion
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding | Surgical and medical procedures | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pauline Chirouze | WOMED | 0785225561 | +33 | pauline@womedtech.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 27, 2020 | Aug 31, 2021 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D006175 | Gynatresia |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| During operation: T=0 |
| Womed Leaf Residuals | Presence of Womed Leaf residuals in the uterus | 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 | At second look hysteroscopy: 4-8 weeks |
| Device Manipulation | Device manipulation duration from insertion to withdrawal. | 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 | At second look hysteroscopy: 4-8 weeks |
| Nîmes |
| France |
| CHU Bicêtre (APHP) | Paris | France |
| Bergman Clinics | Amsterdam | Netherlands |
| Zaans Medical Center | Amsterdam | Netherlands |
| Isala Zwolle | Zwolle | Netherlands |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Myoma type (FIGO classification) | Count of Participants | Participants |
|
| Mean number of tumor resected | Mean | Standard Deviation | tumors resected |
|
| Participants |
|
|
| Primary | Efficacy (Rate of Patient With no IUA) | Freedom from intrauterine adhesion | Posted | Count of Participants | Participants | At second look hysteroscopy between 4 and 8 weeks |
|
|
|
| Primary | 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 | Posted | Count of Participants | Participants | At second look hysteroscopy between 4 and 8 weeks |
|
|
|
| Primary | 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 | Posted | Count of Participants | Participants | At second look hysteroscopy between 4 and 8 weeks |
|
|
|
| Secondary | Adverse Events | Number of adverse events (AE) at 30 days | Posted | Number | adverse events | 30 days |
|
|
|
| Secondary | Device Technical Success | Defined as the rate of success of the following 2 steps : insertion and release | Posted | Count of Participants | Participants | During operation: T=0 |
|
|
|
| Secondary | Womed Leaf Residuals | Presence of Womed Leaf residuals in the uterus | Posted | Count of Participants | Participants | At second look hysteroscopy: 4-8 weeks |
|
|
|
| Secondary | 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 | 10 patients did not notice the discharge of the device | Posted | Median | Full Range | days | At second look hysteroscopy: 4-8 weeks |
|
|
|
| Secondary | Device Manipulation | Device manipulation duration from insertion to withdrawal. | Posted | Mean | Standard Deviation | minutes | During intervention: T=0 |
|
|
|
| Secondary | 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 | 10 patients did not notice the discharge of the device | Posted | Mean | Standard Deviation | scale from 1 (no discomfort) to 10 | At second look hysteroscopy: 4-8 weeks |
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 3 |
| 23 |
| renal colic | General disorders | Non-systematic Assessment |
|
| Hematoma | Surgical and medical procedures | Non-systematic Assessment |
|
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| D000091662 | Genital Diseases |