Evaluate Formation of IUAs After Third-generation Endometrial Ablation, With and Without Intrauterine Adhesion Barrier (CLEAN)

Remko P. Bosgraaf

Status

Completed

Conditions

Intrauterine Adhesion

Asherman Syndrome

Treatments

Device: Womed Leaf

Study type

Interventional

Funder types

Other

Identifiers

NCT05414760

CLEAN

Details and patient eligibility

About

Evaluate the formation of adhesions after third-generation endometrial ablation, with and without the intrauterine adhesion barrier.

Full description

The application of endometrial ablation (EA) has significantly increased in the past 10 years. It is an effective treatment for heavy menstrual bleeding with functional aetiology. However, the risk of post-ablative intracavitary scarring after EA is significant and can lead to long term complications, and the possible delay in diagnosing endometrial cancer. CLEAN is a prospective, multi-center, randomized, controlled, two arm pilot clinical trial. The objective is to compare the formation of adhesions after third-generation endometrial ablation, with and without the intrauterine adhesion barrier.

The study will be performed on women with heavy menstrual bleeding (menorrhagia) scheduled for thermal endometrial ablation with Novasure system (Hologic) A follow-up diagnostic hysteroscopy will be performed 4-8 weeks after the ablation procedure to determine the presence and severity of IUAs according to the American Fertility Society.

Enrollment

1 patient

Sex

Female

Ages

30+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient with refractory heavy menstrual bleeding scheduled for endometrial ablation with Novasure system
Women 30 years old or older;
Subjects who are willing to provide a written informed consent as approved by the applicable Ethics Committee / IRB prior to participating in this clinical investigation.
Subjects who can comply with the study follow-up and other study requirements.

Exclusion criteria

Cavity length <4 or >8
Perforation during ablation procedure
Previous adhesiolysis procedure or diagnosis of Asherman's disease.
Abnormal uterine cavity at the time of ablation according to ESHRE classification I to V such as unicornis, bicornis, septate, duplex
History of cervical or endometrial cancer
Active pelvic infection or history of pelvic peritonitis
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.