New uterine membrane to prevent synechiae
Summary description of the study
The study aims to demonstrate the effectiveness of the Womed Leaf in reducing the severity of synechiae after an adhesiolysis procedure. During the study, participants will be randomly assigned to 2 groups: the first, called the intervention group, will receive the Womed Leaf device, and the second, called the control group, will follow standard care. In Switzerland, there is no standard treatment to prevent the recurrence of synechiae following an adhesiolysis, so the control group will not receive any additional treatment. Assignment to a group is done randomly, by drawing lots. In practice, at the beginning of the hysteroscopy (under general anesthesia), the surgeon will assess the extent and type of synechiae. Only patients with synechiae classified as moderate or severe are eligible for the study. If this is the case, the patient agrees to participate, and no contraindication to her participation is discovered during surgery, a draw will determine whether she receives the device or not. At the end of the operative hysteroscopy, if she is in the intervention group, the surgeon will place the Womed Leaf membrane using a small applicator in her uterus. If she is in the control group, she will not receive any device. Furthermore, the study is double-blind, so the patient will not know which group she belongs to. Participation in this trial does not change the usual follow-up of an operative hysteroscopy: the patient will therefore be invited for a control hysteroscopy 4 to 8 weeks after the intervention. The doctor will reassess her uterine cavity. On this occasion, he will also review her health status to ensure that the postoperative outcomes are satisfactory and to look for any potential side effects. One year and two years after the operation, the patient will be contacted by phone. She will be asked if she has been or is still pregnant.
(BASEC)
Intervention under investigation
Cure of synechia
(BASEC)
Disease under investigation
Synechia / intrauterine adhesion / Asherman syndrome
(BASEC)
Patient with moderate or severe synechiae for whom a cure of synechia by hysteroscopy is planned. (BASEC)
Exclusion criteria
Preoperative exclusion criteria: Postmenopausal; Abnormal uterine cavity such as: unicornuate, bicornuate, septate, duplex; Known or suspected endometrial hyperplasia; Medical history of cervical or endometrial cancer; Active pelvic infection or medical history of pelvic peritonitis; History of endometrial ablation (BASEC)
Trial sites
Lausanne
(BASEC)
Sponsor
Sponsor: Womed sponsor's representative in Switzerland: Confinis AG
(BASEC)
Contact
Contact Person Switzerland
Pauline Chirouze
+33785225561
clinical@clutterwomedtech.comWomed
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Vaud
(BASEC)
Date of authorisation
10.02.2023
(BASEC)
ICTRP Trial ID
NCT04963179 (ICTRP)
Official title (approved by ethics committee)
PRÉvention des adhérences intra-utérines suite à une adhésiolyse grâce à un nouveau film en polymère déGradable: PREG2 (BASEC)
Academic title
PREvention of Intrauterine Adhesion After Adhesiolysis With Novel Tri-block deGradable Polymer Film. (ICTRP)
Public title
PREvention of Intrauterine Adhesion After Adhesiolysis With Novel Tri-block deGradable Polymer Film. (ICTRP)
Disease under investigation
Asherman Syndrome;Intrauterine Adhesion (ICTRP)
Intervention under investigation
Device: Womed Leaf (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Outcomes Assessor). (ICTRP)
Inclusion/Exclusion criteria
Gender: Female
Maximum age: N/A
Minimum age: 18 Years
Inclusion Criteria:
- Women with moderate or severe intrauterine adhesions according to the AFS
classification, i.e AFS score >=5, confirmed by hysteroscopy right before adhesiolysis
- Scheduled for hysteroscopic adhesiolysis
- Age above or equal to 18
- Subjects who are willing to provide a written informed consent.
- Subjects who can comply with the study follow-up (second look hysteroscopy) and other
study requirements
- Subjects who agree to refrain from intercourse or use a reliable form of barrier
contraception to prevent unintended pregnancy until the follow-up hysteroscopy.
- Subjects who agree to avoid all intrauterine devices (IUDs) until the follow-up
hysteroscopy.
Exclusion Criteria:
Pre-operative criteria
- Post menopause
- Pregnant (confirmed by a positive pregnancy test) or lactating
- Abnormal uterine cavity according to ESHRE classification I to V such as unicornis,
bicornis, septate, duplex
- Known or suspected endometrial hyperplasia
- History of cervical or endometrial cancer
- Active pelvic infection or history of pelvic peritonitis
- History of endometrial ablation
- Known contraindication or hypersensitivity to Womed Leaf component
- Current participation in another clinical investigation that has not yet received the
primary endpoint.
- Any other condition that makes participation in the study contrary to the patient's
best interests.
Intra-operative criteria, post adhesiolysis:
- Perforation during adhesiolysis
- Uterine depth < 5cm or > 10cm
(ICTRP)
not available
Primary and secondary end points
Efficacy - IUA severity;Safety - Adverse events (ICTRP)
High-responder rate;Change of "extent of cavity involved" component;Change in "extent of cavity involved" component between post-adhesiolysis and second look hysteroscopy;AFS score;Change of extent of IUA AFS score component;Change of type of IUA AFS score component;Menstrual pattern AFS score component;Percentage of patients who have Mild adhesions or no adhesion;Freedom from IUA;ESGE stage;Level of post-operative pain;Level of discomfort related to vaginal discharge;Timing of vaginal discharge;Duration of the vaginal discharge;Qualitative description of the vaginal discharge;Change of menstrual pattern;Reintervention rate;Number of adhesiolysis procedures;Pregnancy rate;Live birth rate;Pregnancy complication rate;Time to pregnancy;IUA severity according to Chinese scoring system;Responder rate (ICTRP)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
PREG2 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT04963179 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available