NCT05722028

Predictive Factors for Successful Operative Hysteroscopy Using Tissue Removal Device (TruClear System) Without Anesthesia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 70 (actual)
• Sponsor: Assaf-Harofeh Medical Center · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: —

Summary

Background: Small-diameter operative hysteroscopes may allow to perform operative hysteroscopy without general anesthesia in selected patients. One of these instruments is the tissue removal device (TRD), which resects and removes intrauterine pathology such as endometrial polyps and retained products of conception (RPOC) with a diameter of ¬6 mm. Objective: To assess the success rate and intraoperative pain of patients undergoing operative hysteroscopy without anesthesia with the TRD (TruClear Elite Mini-Hysteroscope) for removal of endometrial polyps or RPOC. Methods: Prospective observational study. Participation in the study was offered to patients diagnosed with uterine polyps or RPOC on office diagnostic hysteroscopy. The patients filled out a digital questionnaire before and after the operation. A successful procedure was defined as complete hysteroscopic removal of the uterine pathology using the TruClear system. Oral 400 mcg misoprostol 12 hours before the procedure was prescribed for cervical ripening.

Conditions

• Uterine Polyp
• Retained Products of Conception

Interventions

Type	Name	Description
PROCEDURE	hysteroscopy	Surgical hysteroscopy without anaesthesia for removal of uterine polyp / retained products of conception.

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-08-31
• Completion: 2023-08-31
• First posted: 2023-02-10
• Last updated: 2024-09-27

Locations

1 site across 1 country: Israel

Regulatory

• FDA-regulated device study