RECRUITING

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

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2022-11-22

Study Completion:2025-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05583734

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.

Ages Eligible for Study:21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* • Patients with a previous bone marrow disorder diagnosis who will require multiple bone marrow biopsies over the course of their treatment, for example patients with plasma cell dyscrasia or leukemia. * Men and non-pregnant women of age ≥ 21 years with ECOG performance status ≤ 2. * Any hematologic (platelets above 50, ANC \> 1.0, hemoglobin \> 7), renal (patients not on dialysis), or hepatic (patients with bilirubin below 2.5) function status suitable to undergo port implantation and subsequent bone marrow biopsies. * Patients must be able to understand and be willing to sign a voluntary informed consent form and agree to compliance with the protocol schedule; with the knowledge that they may withdraw consent at any time without impact on future medical care.	* • Patients with any other ongoing, concomitant, comorbid illness including but not limited to uncontrolled diabetes, NYHA class III or worse heart failure, uncontrolled coronary artery disease/arrhythmia. * Patients unable to comply with the study schema. * Confirmed pregnancy at time of screening or on implantation day prior to anesthesia/sedation. * Patients unable to come off of anticoagulation medications for their procedure. * Patients with active infection. * Patients with \< 0.5 cm or \> 2.5 cm of soft tissue between screw head and skin at the target site of implantation. This is based on the patient's prior imaging studies (i.e. CT/MR or ultrasound imaging). * Patient has contra-indication to conscious sedation or anesthesia services * Patients who have had prior bone marrow biopsy within 2 weeks of the study biopsy. * Patients with coagulopathy such that INR cannot be corrected \< 2.0. * Patients who are prisoners or wards of the court. * Patients with alcohol or substance abuse disorder defined by DSM V criteria. * Patients with the diagnosis of a major psychiatric disorder such as schizophrenia or major depression defined by the DSM-V criteria. * Patients with osteoporosis defined as L1 vertebrae bone density lower than 90 Hounsfield units

Inclusion Criteria

Exclusion Criteria

* • Patients with a previous bone marrow disorder diagnosis who will require multiple bone marrow biopsies over the course of their treatment, for example patients with plasma cell dyscrasia or leukemia.
* Men and non-pregnant women of age ≥ 21 years with ECOG performance status ≤ 2.
* Any hematologic (platelets above 50, ANC \> 1.0, hemoglobin \> 7), renal (patients not on dialysis), or hepatic (patients with bilirubin below 2.5) function status suitable to undergo port implantation and subsequent bone marrow biopsies.
* Patients must be able to understand and be willing to sign a voluntary informed consent form and agree to compliance with the protocol schedule; with the knowledge that they may withdraw consent at any time without impact on future medical care.

* • Patients with any other ongoing, concomitant, comorbid illness including but not limited to uncontrolled diabetes, NYHA class III or worse heart failure, uncontrolled coronary artery disease/arrhythmia.
* Patients unable to comply with the study schema.
* Confirmed pregnancy at time of screening or on implantation day prior to anesthesia/sedation.
* Patients unable to come off of anticoagulation medications for their procedure.
* Patients with active infection.
* Patients with \< 0.5 cm or \> 2.5 cm of soft tissue between screw head and skin at the target site of implantation. This is based on the patient's prior imaging studies (i.e. CT/MR or ultrasound imaging).
* Patient has contra-indication to conscious sedation or anesthesia services
* Patients who have had prior bone marrow biopsy within 2 weeks of the study biopsy.
* Patients with coagulopathy such that INR cannot be corrected \< 2.0.
* Patients who are prisoners or wards of the court.
* Patients with alcohol or substance abuse disorder defined by DSM V criteria.
* Patients with the diagnosis of a major psychiatric disorder such as schizophrenia or major depression defined by the DSM-V criteria.
* Patients with osteoporosis defined as L1 vertebrae bone density lower than 90 Hounsfield units

Contacts and Locations

Study Contact

S Solomon

CONTACT

6468663882

info@aperturemed.com

Bob Rioux

CONTACT

508 561 7491

Principal Investigator

Rahul Sheth

PRINCIPAL_INVESTIGATOR

MD Anderson

Study Locations (Sites)

MD Anderson

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Aperture Medical Technology, LLC

Rahul Sheth, PRINCIPAL_INVESTIGATOR, MD Anderson

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 Registration Dates

Study Start Date2022-11-22

Study Completion Date2025-10

Study Record Updates

Study Start Date2022-11-22

Study Completion Date2025-10

Terms related to this study

Additional Relevant MeSH Terms

Hematologic Malignancy