Status:
COMPLETED
Evaluate Formation of IUAs After Third-generation Endometrial Ablation, With and Without Intrauterine Adhesion Barrier
Lead Sponsor:
Remko P. Bosgraaf
Conditions:
Asherman Syndrome
Intrauterine Adhesion
Eligibility:
FEMALE
30+ years
Phase:
NA
Brief Summary
Evaluate the formation of adhesions after third-generation endometrial ablation, with and without the intrauterine adhesion barrier.
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 5 2024
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT05414760
Start Date
November 11 2022
End Date
February 5 2024
Last Update
February 7 2024
Active Locations (2)
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1
Catharina Hospital
Eindhoven, Netherlands, 5623EJ
2
St. Jans Gasthuis
Weert, Netherlands, 6001BE