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Pipelle Versus Karman Endometrial Biopsy Under Standardized Paracervical Block

NCT07366814 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2026-02-10

No results posted yet for this study

Summary

Endometrial biopsy is a commonly used outpatient procedure to evaluate abnormal uterine bleeding and postmenopausal bleeding. Different sampling methods are available, but their diagnostic adequacy and patient experience may vary.

This prospective randomized study compares two commonly used endometrial biopsy methods, Pipelle and Karman cannula, under standardized paracervical block anesthesia. All participants receive the same local anesthetic technique to minimize pain-related differences between methods.

The primary objective is to compare the rate of clinically adequate endometrial samples obtained with each method. Secondary outcomes include patient-reported pain, patient satisfaction, procedure duration, need for additional diagnostic procedures, and hospital-related costs.

Study findings are expected to support clinical decision-making regarding the most effective and practical endometrial biopsy method when adequate pain control is provided.

Conditions

  • Abnormal Uterine Bleeding
  • Postmenopausal Bleeding

Interventions

DEVICE

Pipelle Endometrial Biopsy

Endometrial sampling performed using a Pipelle device in an outpatient setting. The procedure is conducted under standardized paracervical block anesthesia using the same anesthetic agent, dose, and technique for all participants.

DEVICE

Karman Cannula Endometrial Biopsy

Endometrial sampling performed using a Karman cannula in an outpatient setting. The procedure is conducted under standardized paracervical block anesthesia using the same anesthetic agent, dose, and technique for all participants.

Sponsors & Collaborators

  • Gaziosmanpasa Research and Education Hospital

    lead OTHER_GOV

Principal Investigators

  • Fatma Ketenci Gencer, Assoc. Prof. · University of Health Sciences, Gaziosmanpaşa Training and Research Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-03
Primary Completion
2026-01-31
Completion
2026-02-09

Countries

  • Turkey (Türkiye)

Study Locations

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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 NCT07366814 on ClinicalTrials.gov