5Fr Bipolar Electrode vs. Conical Optical 5Fr Fibers for Dual Wave-length Diode Laser for Hystero… (NCT06526962) | Clinical Trial Compass
RecruitingNot Applicable
5Fr Bipolar Electrode vs. Conical Optical 5Fr Fibers for Dual Wave-length Diode Laser for Hysteroscopic Polypectomy
Italy214 participantsStarted 2024-05-07
Plain-language 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 laser, in performing hysteroscopic polypectomy in an outpatient setting.
Who can participate
Age range18 Years – 60 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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.
What they're measuring
1
Time required to perform the operative hysteroscopic procedure.