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A Prospective Study of Conventional Bone Marrow Biopsy Versus Portomar(TM) Biopsy

Hematologic Malignancy Clinical Trial

Official title:
A Prospective Study of Conventional Bone Marrow Biopsies and Bone Marrow Biopsies Performed Through the Portomar(TM), Using a Modified PROMIS Pain Intensity Scale for Pain Assessment

Clinical Trial Summary

This is a self-controlled, prospective trial. The objective of this trial is to evaluate the efficacy and safety of the Portomar(TM) device for bone marrow biopsy.

Clinical Trial Description

This is a self-controlled, prospective trial. Subjects will undergo conventional bone marrow biopsy compared to bone marrow biopsy with the Portomar(TM) device. Subjects will be evaluated at multiple time points comparing the two biopsies. Data through the 6 month time point will be used for Regulatory Submission to the FDA. Additionally subjects will be followed for two years post enrollment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05583734
Study type Interventional
Source Aperture Medical Technology, LLC
Contact S Solomon
Phone 6468663882
Email info@aperturemed.com
Status Recruiting
Phase N/A
Start date November 22, 2022
Completion date October 2025
View Details
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