Pipelle Versus Karman Endometrial Biopsy Under Standardized Paracervical Block

NCT07366814 | Completed

• 1 other identifier: EK-193-2025-EMB
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Endometrial Biopsy; Pipelle; Karman Cannula; Paracervical Block; Abnormal Uterine Bleeding; Postmenopausal Bleeding; Diagnostic Adequacy; Patient Satisfaction

Outcome Measures

Primary Outcomes (1)

• Clinically Adequate Endometrial Sample Rate

  Proportion of endometrial biopsy samples considered clinically adequate for diagnosis based on blinded histopathological assessment.

  At the index procedure (same day)

Secondary Outcomes (5)

• Procedure-Related Pain Score

  Periprocedural

• Patient Satisfaction With the Procedure

  Same day after the procedure

• Procedure Duration

  During the procedure

• Need for Additional Diagnostic Procedures

  Within 2 weeks after the procedure

• Hospital-Related Cost per Participant

  Within 2 weeks after the procedure

Study Arms (2)

Pipelle Endometrial Biopsy

EXPERIMENTAL

Participants assigned to this arm undergo office-based endometrial biopsy using a Pipelle device. All procedures are performed under standardized paracervical block anesthesia with the same anesthetic agent, dose, and technique as the other study arm.

Device: Pipelle Endometrial Biopsy

Karman Endometrial Biopsy

EXPERIMENTAL

Participants assigned to this arm undergo office-based endometrial sampling using a Karman cannula. All procedures are performed under standardized paracervical block anesthesia with the same anesthetic agent, dose, and technique as the other study arm.

Device: Karman Cannula Endometrial Biopsy

Interventions

Karman Cannula Endometrial Biopsy DEVICE

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.

Also known as: Karman Cannula, Manual Vacuum Aspiration Cannula

Karman Endometrial Biopsy

Pipelle Endometrial Biopsy DEVICE

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.

Also known as: Pipelle de Cornier

Pipelle Endometrial Biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female participants aged 18 years or older
• Abnormal uterine bleeding or postmenopausal bleeding requiring endometrial sampling
• Ability to provide written informed consent
• Eligible for office-based endometrial biopsy

You may not qualify if:

• Pregnancy
• Active pelvic infection
• Known cervical or endometrial cancer
• Severe cervical stenosis preventing endometrial sampling
• Known bleeding disorders or use of anticoagulant therapy that contraindicates biopsy
• Inability or unwillingness to provide informed consent

Sponsors & Collaborators

• Gaziosmanpasa Research and Education Hospital: lead

Study Sites (1)

University of Health Sciences, Gaziosmanpaşa Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• Coskun ES, Yeniocak AS, Bacak HB, Salman S. Optimizing analgesia for endometrial biopsy: A prospective, randomized comparative study. J Obstet Gynaecol Res. 2025 Jan;51(1):e16148. doi: 10.1111/jog.16148. Epub 2024 Nov 17.

  PMID: 39551483 RESULT

MeSH Terms

Conditions

Metrorrhagia; Patient Satisfaction

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Fatma Ketenci Gencer, Assoc. Prof.

  University of Health Sciences, Gaziosmanpaşa Training and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Histopathological evaluation of endometrial samples is performed by pathologists who are blinded to the biopsy method used.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Eligible participants are randomly assigned in a 1:1 ratio to undergo endometrial biopsy using either the Pipelle device or the Karman cannula, with both groups treated concurrently.

Study Record Dates

• First Submitted: January 3, 2026
• First Posted: January 26, 2026
• Study Start: January 3, 2026
• Primary Completion: January 31, 2026
• Study Completion: February 9, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)