New uterine membrane to prevent synechiae
Résumé de l'étude
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 étudiée
Cure of synechia
(BASEC)
Maladie en cours d'investigation
Synechia / intrauterine adhesion / Asherman syndrome
(BASEC)
Patient with moderate or severe synechiae for whom a cure of synechia by hysteroscopy is planned. (BASEC)
Critères d'exclusion
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)
Lieu de l’étude
Lausanne
(BASEC)
Sponsor
Sponsor: Womed sponsor's representative in Switzerland: Confinis AG
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Pauline Chirouze
+33785225561
clinical@clutterwomedtech.comWomed
(BASEC)
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique du Vaud
(BASEC)
Date d'approbation du comité d'éthique
10.02.2023
(BASEC)
Identifiant de l'essai ICTRP
NCT04963179 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
PRÉvention des adhérences intra-utérines suite à une adhésiolyse grâce à un nouveau film en polymère déGradable: PREG2 (BASEC)
Titre académique
PREvention of Intrauterine Adhesion After Adhesiolysis With Novel Tri-block deGradable Polymer Film. (ICTRP)
Titre public
PREvention of Intrauterine Adhesion After Adhesiolysis With Novel Tri-block deGradable Polymer Film. (ICTRP)
Maladie en cours d'investigation
Asherman Syndrome;Intrauterine Adhesion (ICTRP)
Intervention étudiée
Device: Womed Leaf (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Outcomes Assessor). (ICTRP)
Critères d'inclusion/exclusion
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)
non disponible
Critères d'évaluation principaux et secondaires
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)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
non disponible
Contacts supplémentaires
non disponible
ID secondaires
PREG2 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT04963179 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible