MedTrace Logo

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

NCT05722028 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2024-09-27

No results posted yet for this study

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

PROCEDURE

hysteroscopy

Surgical hysteroscopy without anaesthesia for removal of uterine polyp / retained products of conception.

Sponsors & Collaborators

  • Assaf-Harofeh Medical Center

    lead OTHER_GOV

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2023-08-31
Completion
2023-08-31
FDA Device
Yes

Countries

  • Israel

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05722028 on ClinicalTrials.gov