Hematologic MalignancyNCT05583734
A Prospective Study of Conventional Bone Marrow Biopsy Versus Portomar(TM) Biopsy
A study testing Portomar(TM) Device in people with Hematologic Malignancy, run by Aperture Medical Technology, LLC at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hematologic Malignancy
- What is being tested?
- Portomar(TM) Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2022to Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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.
Who cannot join
- • 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).
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- 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
Trial locations and contacts
1 site in 1 country.
Bob Rioux contact
United States1 site, 1 recruiting
- Recruiting
MD Anderson
Houston, Texas, 77030
Rahul Sheth, MD, 713-745-4794
About this study
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
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.
Read the 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
- Being tested
- Portomar(TM) Device
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portomar(TM) DeviceDevice
Portomar(TM) access device for bone marrow biopsy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Portomar(TM) Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Day of placement (beginning of study)
Portomar(TM) pain intensity
Pain related to Portomar(TM) will be assessed using the same modified NCI PROMIS
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 90 days after study begins with Portomar(TM) placement
Secondary outcomes (6)
Safety Events
Adverse events
Measured: Study duration, approximately 2 years
Satisfaction Score
Patient and practitioner satisfaction questionnaires
Measured: 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
Pain from Portomar(TM) and bone marrow biopsies. The modified PROMIS scale 0-10 will be used.
Measured: Study duration (approximately 2 years) at all bone marrow biopsies with Portomar(TM)
Specimen-Core Biopsy
Adequacy. This will be judged by the proportion of biopsies at least 1.2 cm length.
Measured: Study duration (approximately 2 years) at all bone marrow biopsied performed with Portomar(TM)
Specimen-Aspirate
Adequacy This will be judged by the proportion of aspirations with at least 1 spicule seen.
Measured: Study duration (approximately 2 years) at all bone marrow biopsied performed with Portomar(TM)
Time
Time from needle anesthetic to sample acquired. Comparison of conventional vs. Portomar(TM).
Measured: Study duration (approximately 2 years) at all bone marrow biopsied performed with Portomar(TM)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start22 Nov 2022
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Self-controlled, prospective trial
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aperture Medical Technology, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rahul Sheth, Principal investigator, MD Anderson
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05583734
- Sponsor's protocol ID
- Study Number: 1339403
- Status last verified
- Apr 2024
- First submitted
- 29 Sep 2022
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05583734
- Acronym / sponsor ID
- Study Number: 1339403
- Conditions
- Hematologic Malignancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Aperture Medical Technology, LLCIndustry (pharma, biotech, devices)
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 18 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Self-controlled, prospective trial
| Arm | Type | Receives |
|---|---|---|
| Portomar(TM) Device | Experimental | Device: Portomar(TM) DevicePortomar(TM) Device for bone marrow biopsy Subjects are self-controlled with one side having conventional biopsy and the other having the Portomar(TM) biopsy. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • 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.
Key exclusion criteria (13 listed)
- • 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Portomar(TM) DevicePortomar(TM) access device for bone marrow biopsy | Device | Portomar(TM) Device |
Primary outcome
Pain intensity
Time frame: Day of bone marrow biopsy (approximately 1 month after Portomar(TM) placement)
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.
Portomar(TM) pain intensity
Time frame: Day of placement (beginning of study)
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).
Portomar(TM) pain intensity
Time frame: 1 day after study begins with Portomar(TM) placement
Pain related to Portomar(TM) will be assessed using the same modified NCI PROMIS
Portomar(TM) pain intensity
Time frame: 2 days after study begins with Portomar(TM) placement
Pain related to Portomar(TM) will be assessed using the same modified NCI PROMIS
Portomar(TM) pain intensity
Time frame: 7 days after study begins with Portomar(TM) placement
Pain related to Portomar(TM) will be assessed using the same modified NCI PROMIS
Portomar(TM) pain intensity
Time frame: 14 days after study begins with Portomar(TM) placement
Pain related to Portomar(TM) will be assessed using the same modified NCI PROMIS
Portomar(TM) pain intensity
Time frame: 30 days after study begins with Portomar(TM) placement
Pain related to Portomar(TM) will be assessed using the same modified NCI PROMIS
Portomar(TM) pain intensity
Time frame: 90 days after study begins with Portomar(TM) placement
Pain related to Portomar(TM) will be assessed using the same modified NCI PROMIS
6 secondary outcomes
Safety Events
Time frame: Study duration, approximately 2 years
Satisfaction Score
Time frame: 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
Time frame: Study duration (approximately 2 years) at all bone marrow biopsies with Portomar(TM)
Specimen-Core Biopsy
Time frame: Study duration (approximately 2 years) at all bone marrow biopsied performed with Portomar(TM)
Specimen-Aspirate
Time frame: Study duration (approximately 2 years) at all bone marrow biopsied performed with Portomar(TM)
Time
Time frame: Study duration (approximately 2 years) at all bone marrow biopsied performed with Portomar(TM)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bob Rioux contact
Rahul Sheth principal investigator
MD Anderson
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Portomar(TM) Device in people with Hematologic Malignancy, run by Aperture Medical Technology, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact S Solomon (6468663882, info@aperturemed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Day of bone marrow biopsy (approximately 1 month after Portomar(TM) placement)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.