Pipelle vs the Curved Aspirator Device

Conditions

• Endometrial Biopsy

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 95 Years

Healthy Volunteers

Accepted

Interventions

• Curved Tip Aspirator — DEVICE
  Curved Tip Aspirator; Endomitrial Biopsy Devise
• Pipelle — DEVICE
  Pipelle; Endomitrial Biopsy Devise

Study Details

The primary aim of this study is to rigorously compare the efficacy of two commonly used endometrial sampling devices, the Pipelle and the Miltex, these devices are standard of care at Maimonides. This primary objective is critical, as the ability to accurately reach the uterine cavity is fundamental to obtaining adequate samples for histopathological evaluation, which is crucial for diagnosing endometrial cancer and other uterine pathologies.

Key Dates

Start date

Jan 2, 2026

Status verified

Mar 2026

Primary completion

Dec 31, 2027

Completion

Mar 31, 2028

Study Design

Enrollment

124 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Pipelle
  This arm will receive a biopsy using the pipelle device
• Experimental: Curved tip aspirator
  This arm will receive an endometrial biopsy using the curved tip aspirator.

Primary Outcome Measure

Obtaining an adeuate histiopathologic sample [ Time Frame: 30 minutes ]

Central Contacts

• Olivia OB/GYN research manager
  718-283-7962
  [email protected]

Locations (1)

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