NCT05583734

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Aperture Medical Technology, LLC · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hematologic Malignancy

Interventions

Type	Name	Description
DEVICE	Portomar(TM) Device	Portomar(TM) access device for bone marrow biopsy

Timeline

• Start date: 2022-11-22
• Primary completion: 2025-10-01
• Completion: 2025-10-01
• First posted: 2022-10-18
• Last updated: 2024-04-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study