NCT05583734

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 18, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

November 22, 2022

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

April 23, 2024

Status Verified

April 1, 2024

Enrollment Period

2.9 years

First QC Date

September 29, 2022

Last Update Submit

April 21, 2024

Conditions

Hematologic Malignancy

Outcome Measures

Primary Outcomes (8)

  • Pain intensity

    Pain Comparison- The scale used to assess pain is a modified National Cancer Institute (NCI) Patient Reported Outcome Measurement Information System (PROMIS). Patients are asked to rate their pain intensity from 0 (no pain)-10 (worst pain ever) comparing the bone marrow biopsy performed with the Portomar(TM) device and a standard bone marrow biopsy. The endpoint will be the proportion of patients experiencing at least a 2 point improvement in score between Portomar(TM) and standard biopsy.

    Day of bone marrow biopsy (approximately 1 month after Portomar(TM) placement)

  • Portomar(TM) pain intensity

    Pain related to Portomar(TM) will be assessed using the same modified NCI PROMIS Scale. The endpoint is the proportion of patients experiencing severe pain (\>8).

    Day of placement (beginning of study)

  • Portomar(TM) pain intensity

    Pain related to Portomar(TM) will be assessed using the same modified NCI PROMIS

    1 day after study begins with Portomar(TM) placement

  • Portomar(TM) pain intensity

    Pain related to Portomar(TM) will be assessed using the same modified NCI PROMIS

    2 days after study begins with Portomar(TM) placement

  • Portomar(TM) pain intensity

    Pain related to Portomar(TM) will be assessed using the same modified NCI PROMIS

    7 days after study begins with Portomar(TM) placement

  • Portomar(TM) pain intensity

    Pain related to Portomar(TM) will be assessed using the same modified NCI PROMIS

    14 days after study begins with Portomar(TM) placement

  • Portomar(TM) pain intensity

    Pain related to Portomar(TM) will be assessed using the same modified NCI PROMIS

    30 days after study begins with Portomar(TM) placement

  • Portomar(TM) pain intensity

    Pain related to Portomar(TM) will be assessed using the same modified NCI PROMIS

    90 days after study begins with Portomar(TM) placement

Secondary Outcomes (6)

  • Safety Events

    Study duration, approximately 2 years

  • Satisfaction Score

    Day of placement and every time a bone marrow biopsy is performed using the Portomar(TM) device for study duration approximately 2 years

  • Pain Score

    Study duration (approximately 2 years) at all bone marrow biopsies with Portomar(TM)

  • Specimen-Core Biopsy

    Study duration (approximately 2 years) at all bone marrow biopsied performed with Portomar(TM)

  • Specimen-Aspirate

    Study duration (approximately 2 years) at all bone marrow biopsied performed with Portomar(TM)

  • +1 more secondary outcomes

Study Arms (1)

Portomar(TM) Device

EXPERIMENTAL

Portomar(TM) Device for bone marrow biopsy Subjects are self-controlled with one side having conventional biopsy and the other having the Portomar(TM) biopsy.

Device: Portomar(TM) Device

Interventions

Portomar(TM) DeviceDEVICE

Portomar(TM) access device for bone marrow biopsy

Portomar(TM) Device

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MD Anderson

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Rahul Sheth

    MD Anderson

    PRINCIPAL INVESTIGATOR

Central Study Contacts

S Solomon

CONTACT

6468663882info@aperturemed.com

Bob Rioux

CONTACT

508 561 7491

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Self-controlled, prospective trial
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2022

First Posted

October 18, 2022

Study Start

November 22, 2022

Primary Completion

October 1, 2025

Study Completion

October 1, 2025

Last Updated

April 23, 2024

Record last verified: 2024-04

Locations

US(1)