Recruiting

Conventional Biopsy vs. Portomar(TM) Biopsy

Sponsor:

Aperture Medical Technology, LLC

Code:

NCT05583734

Conditions

Hematologic Malignancy

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Portomar(TM) Device

Study Details

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.

Conditions

Hematologic Malignancy

Study ID

NCT05583734

Start date

Nov 22, 2022

Status verified date

Apr, 2024

Completion date

Oct, 2025

Anticipated

Primary completion date

Oct, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Inclusion 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.

Exclusion Criteria:

  • • 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

Study Design

Enrollment

32 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Portomar(TM) Device

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.

Interventions

Portomar(TM) Device

Portomar(TM) access device for bone marrow biopsy

Primary outcome measure

  • Pain intensity [ Time Frame: Day of bone marrow biopsy (approximately 1 month after Portomar(TM) placement) ]
  • Portomar(TM) pain intensity [ Time Frame: Day of placement (beginning of study) ]
  • Portomar(TM) pain intensity [ Time Frame: 1 day after study begins with Portomar(TM) placement ]
  • Portomar(TM) pain intensity [ Time Frame: 2 days after study begins with Portomar(TM) placement ]
  • Portomar(TM) pain intensity [ Time Frame: 7 days after study begins with Portomar(TM) placement ]
  • Portomar(TM) pain intensity [ Time Frame: 14 days after study begins with Portomar(TM) placement ]
  • Portomar(TM) pain intensity [ Time Frame: 30 days after study begins with Portomar(TM) placement ]
  • Portomar(TM) pain intensity [ Time Frame: 90 days after study begins with Portomar(TM) placement ]

Central Contacts and Locations

Central contacts

S Solomon

6468663882info@aperturemed.com

Bob Rioux

508 561 7491

Locations

MD Anderson

Recruiting

Houston, Texas, United States, 77030

Contacts

Rahul Sheth, MD

713-745-4794

More Information

Sponsor

Aperture Medical Technology, LLC

Last update posted

Apr 23, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Aperture Medical Technology, LLC on 2024-04-23.