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 range
18 Years – 60 Years
Sex
FEMALE
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time required to perform the operative hysteroscopic procedure.