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

NCT05722028 | Completed FDA Device

• 1 other identifier: 123456
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Procedure completed successfully

  Was the procedure completed - yes/no

  Immediately after procedure

Secondary Outcomes (4)

• Prevalence of VAS (pain scale) > 5 during procedure

  Immediately after procedure

• Prevalence of VAS (pain scale) > 5, five minutes after procedure

  5 minutes after procedure

• Acceptable procedure by the patient

  5 minutes after procedure

• Recommended procedure by the patient

  5 minutes after procedure

Study Arms (1)

Patients with benign uterine findings (polyp / retained products of conception)

Female patients undergoing diagnostic hysteroscopy with a diagnosis of uterine polyp or retained products of conception. These patients are then invited to a surgical office procedure without anaesthesia to remove these findings.

Procedure: hysteroscopy

Interventions

hysteroscopy PROCEDURE

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

Patients with benign uterine findings (polyp / retained products of conception)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women who have been diagnosed with a benign pathology (polyp or retained products of conception) in diagnostic hysteroscopy and are accepted for surgical hysteroscopy in a clinical setting (without anesthesia) for its removal.

You may qualify if:

• Diagnosis of polyp or retained products of conception in diagnostic hysteroscopy.
• Medical need to remove the finding according to accepted criteria.
• Patient's consent to the removal of the finding in a procedure without anesthesia.
• Patient's consent to participate in the study.

You may not qualify if:

• Any indication for performing the procedure under anesthesia in an operating room, such as:
• Medical background requiring operation in an operating room.
• Personal / mental background requiring procedure under general anesthesia.
• Cervical stenosis
• Previous failure to remove the finding in a procedure without anesthesia
• Lack of response to performing the operation without anesthesia
• The lack of response to participate in the study
• A known diagnosis of malignancy from a previous sample of the polyp or endometrium

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

Shamir medical center

Zrifin, Israel

Location

MeSH Terms

Interventions

Hysteroscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Obstetric Surgical Procedures; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: investigator

Study Record Dates

• First Submitted: January 29, 2023
• First Posted: February 10, 2023
• Study Start: August 1, 2022
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: September 27, 2024

Record last verified: 2024-09

Locations

IL (1)