Pipelle vs the Curved Aspirator Device
ConditionEndometrial Biopsy
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-95
SponsorJefferson Drapkin
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients <18- 45 years with risk factors for endometrial cancer requiring endometrial biopsy.
Patients ≥ 45 -95 years with abnormal uterine bleeding.
Postmenopausal patients with bleeding or suspected endometrial pathology
Disqualifiers
Any patient who does not meet the inclusion criteria.
Pregnancy
Acute pelvic inflammatory disease
Acute cervical infection
Trial design
Design model
Parallel
Treatments tested in this trial
Curved Tip Aspirator
DeviceCurved Tip Aspirator; Endomitrial Biopsy Devise
Pipelle
DevicePipelle; Endomitrial Biopsy Devise
Treatment groups
124 Participants
are divided into 2 treatment groupsGroup A: PipelleActive comparator 1 intervention
Group B: Curved tip aspiratorExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Obtaining an adeuate histiopathologic sample
defined as the inability to insert the sampler through the external or internal os after two attempts (determined by passing the external os \<6cm)
Time frame
30 minutesSponsors and contacts
Click on the lead sponsor to view all of their trials.
Jefferson Drapkin
Lead sponsor
Maimonides Medical Center
Sponsor institution
Source ClinicalTrials.gov