Status:
RECRUITING
5Fr Bipolar Electrode vs. Conical Optical 5Fr Fibers for Dual Wave-length Diode Laser for Hysteroscopic Polypectomy
Lead Sponsor:
University of Cagliari
Conditions:
Endometrial Polyp
Eligibility:
FEMALE
18-60 years
Brief Summary
The primary objective of this study is to compare the performance of two different surgical instruments, the 5 Fr bipolar electrode and the 5 Fr angled conical optical fiber for dual wavelength diode ...
Detailed Description
More specifically, the study aims to compare these instruments by evaluating the following parameters: * Duration of the procedure; * Use of any additional accessory instrumentation; * Effectiveness ...
Eligibility Criteria
Inclusion
- age ≥18 years and \< 60 years;
- suspicion of a single endometrial polyp, documented by ultrasound, with dimensions less than 20 mm;
- presence of abnormal uterine bleeding or history of infertility (defined as absence of conception after 12 months of regular unprotected intercourse aimed at conception);
- consent to participate in the study.
Exclusion
- presence of multiple endometrial polyps;
- presence of a single endometrial polyp with dimensions greater than 20 mm;
- concurrent presence of intrauterine fibroids, focal or diffuse endometrial thickening, and/or intrauterine adhesions (synechiae);
- current or recent use (\< 3 months) of anticoagulant drugs and/or Selective Estrogen Receptor Modulators (SERMs);
- presence of another known cause of vaginal/cervical bleeding;
- suspected adnexal pathology;
- confirmed diagnosis of endometrial cancer;
- suspected acute pelvic inflammation or recent history of pelvic inflammation (\< 6 months);
- presence of tight cervical canal stenosis;
- requirement for any type of anesthesia to perform the hysteroscopic procedure.
Key Trial Info
Start Date :
May 7 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 7 2025
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT06526962
Start Date
May 7 2024
End Date
May 7 2025
Last Update
July 30 2024
Active Locations (1)
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1
University of Cagliari
Cagliari, Italy, 09042