Pipelle Versus Manual Vacuum Aspiration Cannula for Endometrial Biopsy in Women With Abnormal Uterine Bleeding

July 22, 2026 updated by: DR. IZAM AFZAL, University of Health Sciences Lahore

A Comparative Study of Pipelle Versus Manual Vacuum Aspiration Cannula for Endometrial Biopsy

women globally, often requiring endometrial tissue sampling for accurate evaluation and diagnosis. Traditional office-based sampling techniques like Pipelle are widely used, but the disposable instruments can be relatively expensive in resource-limited settings. Manual Vacuum Aspiration (MVA) using a flexible cannula is an inexpensive, reusable alternative, but clinical data comparing its performance directly to Pipelle remains limited.

The objective of this randomized clinical trial is to compare Pipelle endometrial biopsy and Manual Vacuum Aspiration (MVA) cannula in terms of sample adequacy, patient satisfaction, and post-procedure complications in women presenting with abnormal uterine bleeding. Participants will be randomly assigned to undergo endometrial sampling using either a 4 mm MVA cannula or a Pipelle device without anesthesia or cervical dilation. Samples will be analyzed for histopathological diagnosis, and outcomes such as procedure pain, adequacy of tissue, and complications will be recorded.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Married women aged 35 years and above.
  2. Presentation with abnormal uterine bleeding (AUB), including but not limited to metrorrhagia, menorrhagia, or postmenopausal bleeding.
  3. Clinical indication for endometrial sampling for diagnostic evaluation of abnormal uterine bleeding.
  4. Patient fit for both MVA and Pipelle procedures, with no contraindications to either method.

Exclusion Criteria:

  1. Pregnancy or suspicion of pregnancy.
  2. Acute pelvic inflammatory disease or active genital tract infection.
  3. Current use of anticoagulant therapy or presence of bleeding disorders that pose a risk for excessive bleeding during endometrial sampling.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A: MVA Cannula
Participants assigned to Group A will undergo endometrial tissue sampling using a 4 mm Manual Vacuum Aspiration (MVA) cannula attached to an aspiration syringe without local anesthesia or cervical dilation under aseptic conditions.
Other: Manual Vacuum Aspiration (MVA) Cannula
Endometrial sampling using a 4 mm flexible polyethylene MVA cannula connected to a manual vacuum aspiration syringe without dilation or anesthesia.
Active Comparator: Group B: Pipelle Biopsy
Participants assigned to Group B will undergo endometrial sampling using a standard Pipelle device under aseptic conditions without local anesthesia or cervical dilation. The piston will be withdrawn to create vacuum-assisted suction and rotated to acquire tissue.
Other: Pipelle Endometrial Suction Curette
Endometrial biopsy using a flexible Pipelle device operated by pulling the internal piston to create negative pressure without dilation or anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic Yield for Endometrial Pathology
Time Frame: At the time of histopathological assessment (within 7 days post-procedure)
Proportion of patients receiving a definitive histopathological diagnosis (differentiating benign vs. malignant/premalignant conditions) based on microscopic evaluation by a blinded consultant histopathologist.
At the time of histopathological assessment (within 7 days post-procedure)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Health Sciences Lahore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 11, 2026

Primary Completion (Estimated)

February 15, 2027

Study Completion (Estimated)

August 12, 2027

Study Registration Dates

First Submitted

July 22, 2026

First Submitted That Met QC Criteria

July 22, 2026

First Posted (Actual)

July 28, 2026

Study Record Updates

Last Update Posted (Actual)

July 28, 2026

Last Update Submitted That Met QC Criteria

July 22, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Exp142

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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