Portomar Device for Blood Cancers

Overseen By Bob Rioux

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Aperture Medical Technology, LLC

Must not be taking: Anticoagulants

Disqualifiers: Uncontrolled diabetes, Heart failure, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 month

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Portomar(TM) device to evaluate its effectiveness and safety for bone marrow biopsies in individuals with blood cancers. The trial compares the new device to the standard biopsy method by using both on the same patient. It aims to assist those with blood disorders, such as leukemia, who need multiple biopsies during treatment. Suitable candidates for the trial include individuals diagnosed with a bone marrow disorder who require several biopsies and meet specific health criteria. As an unphased trial, it provides a unique opportunity to contribute to innovative research that could enhance biopsy procedures for future patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are unable to stop taking anticoagulation medications for the procedure.

What prior data suggests that the Portomar(TM) device is safe for bone marrow biopsy?

Research has shown limited information on the safety of the Portomar(TM) device for bone marrow biopsy. Clear data on patient tolerance is lacking. This trial aims to evaluate both the device's effectiveness and safety, indicating that safety is still under investigation. Prospective participants should be aware that the device's safety is not fully established. It is important to consult with a doctor to understand the potential risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Portomar(TM) Device is unique because it offers a new approach to bone marrow biopsies for blood cancers. Typically, bone marrow biopsies are done using conventional needles, which can be painful and invasive. However, the Portomar(TM) Device promises to make this process less invasive by potentially reducing discomfort and recovery time. Researchers are excited because this device could improve patient experience and outcomes by making biopsies more efficient and less stressful.

What evidence suggests that the Portomar(TM) device is effective for bone marrow biopsy?

Research has shown that the Portomar(TM) device is being tested in this trial to evaluate its effectiveness for bone marrow biopsies in blood cancer patients. Although limited published information exists on its efficacy, the device is designed to improve the biopsy process. It aims to make the procedure less painful and quicker than traditional methods. Early feedback from other studies suggests it might offer more comfort for patients. This trial continues to test the device to confirm these benefits in a larger group. ^{3 6 7 8 9}

Who Is on the Research Team?

Rahul Sheth

Principal Investigator

MD Anderson

Are You a Good Fit for This Trial?

This trial is for adults over 21 with certain blood cancers who need multiple bone marrow biopsies. They should be relatively active (ECOG ≤ 2), not pregnant, and have decent blood, kidney, and liver function. Participants must understand the study and agree to follow its rules.

Inclusion Criteria

I am 21 or older, not pregnant, and can care for myself.

I have a bone marrow disorder and will need several bone marrow tests.

I understand the study details and agree to participate willingly.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Subjects undergo conventional bone marrow biopsy and bone marrow biopsy with the Portomar(TM) device

1 month

Day of bone marrow biopsy

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Portomar(TM) Device

Trial Overview The study is testing the Portomar(TM) device's effectiveness and safety in performing bone marrow biopsies compared to traditional methods. It's a self-controlled trial where patients serve as their own comparison group.

How Is the Trial Designed?

Group I: Portomar(TM) Device Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Aperture Medical Technology, LLC

Lead Sponsor

Trials

1

Recruited

30+

Published Research Related to This Trial

Recent advances in thrombotic risk stratification for polycythemia vera (PV) and essential thrombocythemia (ET) have been enhanced by international collaborations and technologies like next-generation sequencing, improving patient care significantly.

Ruxolitinib and interferon have shown excellent efficacy and safety in clinical trials, confirming their effectiveness as both first- and second-line treatments, while early trials of novel agents indicate promising results in managing symptoms and blood counts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in Risk Stratification and Treatment of Polycythemia Vera and Essential Thrombocythemia. Krecak, I., Lucijanic, M., Verstovsek, S.[2022]

Cytoreductive treatments, including phlebotomy and low-dose aspirin, have significantly reduced thrombotic complications in patients with polycythemia vera, leading to improved survival rates.

There is a concern that some myelosuppressive drugs may accelerate the progression of polycythemia vera to acute myeloid leukemia, highlighting the need for careful management to balance reducing thrombotic risks while preventing disease progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based management of polycythemia vera. Barbui, T., Finazzi, G.[2013]

Chronic myeloproliferative neoplasms (MPN) are linked to vascular complications, with clonal hematopoiesis contributing to increased risks of cardiovascular events and solid cancers due to chronic inflammation.

The study suggests that targeting clonal hematopoiesis and inflammation could lead to new antithrombotic therapies, potentially benefiting both MPN patients and the general population, especially the elderly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clonal Hematopoiesis in Myeloproliferative Neoplasms Confers a Predisposition to both Thrombosis and Cancer. Barbui, T., Gavazzi, A., Sciatti, E., et al.[2023]

Polycythemia vera is primarily managed with aspirin and methods to reduce hematocrit, such as venesection or cytoreductive therapy, with hydroxyurea being the first-line treatment for high-risk patients despite its potential toxicities and resistance issues.

The review will evaluate alternative treatments like interferon and ruxolitinib for patients who are resistant to or cannot tolerate hydroxyurea, emphasizing the need for therapies that do not increase the risk of progression to acute leukemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of hydroxyurea resistant or intolerant polycythemia vera. Raman, I., Pasricha, SR., Prince, HM., et al.[2021]

Therapeutic apheresis, which involves separating and removing certain components from the blood, has evolved significantly since its early development in the 1930s, particularly with the introduction of automated cell separators that improved its use in clinical settings.

Current guidelines from the American Society for Apheresis help hematologists make evidence-based decisions regarding the use of therapeutic apheresis for various hematological disorders, including modalities like plasma exchange and leukocytapheresis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indications for therapeutic apheresis in hematological disorders. Szczepiorkowski, ZM.[2021]

Citations

1. ichgcp.net ichgcp.net/clinical-trials-registry/NCT05583734

Portomar(TM) Device in Hematologic Malignancy - ICH GCP The objective of this trial is to evaluate the efficacy and safety of the Portomar(TM) device for bone marrow biopsy. Study Overview. Status.

2. sigma.larvol.com sigma.larvol.com/facility.php?e1=3008&e2=&FacilityId=3008&tab=FacilityOTT&sr=now&er=1+month&ipwnd=on&rlink=,FacilityId=3008,tab=trials,itype=0,1&rflag=1&page=29

University of Texas MD Anderson Cancer Center Trials Portomar(TM) Device. Aperture Medical Technology, LLC. Hematologic Malignancy ... Dec 2022 - Dec 2022: Preliminary efficacy data from TELLOMAK trial for Sezary ...

3. go.drugbank.com go.drugbank.com/conditions/DBCOND0031698

Hematological Malignancy (DBCOND0031698) A nicotinamide-modified allogeneic hematopoietic progenitor cell therapy derived from cord blood indicated for use in patients with hematologic malignancies who ...

4. researchgate.net researchgate.net/publication/355894057_Improved_Chemotherapy_Outcomes_of_Patients_With_Small-cell_Lung_Cancer_Treated_With_Combined_Alkalization_Therapy_and_Intravenous_Vitamin_C

Improved Chemotherapy Outcomes of Patients With Small ... This study indicates that alkalization therapy, when combined with vitamin C, may significantly improve outcomes in SCLC patients. [78] ].

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10188596/

Global burden of hematologic malignancies and evolution ... The results of the study will inform analysis of trends in the global burden of disease for specific hematologic malignancies and develop ...

6. reporter.nih.gov reporter.nih.gov/search/7_NkgDDx30aJw2vBLRmIrA/project-details/11014870

RePORT ⟩ RePORTER We're sorry but RePORTER doesn't work properly without JavaScript enabled. Please enable it to continue.

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05583734/a-prospective-study-of-conventional-bone-marrow-biopsy-versus-portomartm-biopsy

A Prospective Study of Conventional Bone Marrow Biopsy ... The objective of this trial is to evaluate the efficacy and safety of the Portomar(TM) device for bone marrow biopsy. Eligibility Criteria ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05488314

NCT05488314 | A Study of Amivantamab and Capmatinib ... The purpose of this study is to identify the recommended Phase 2 combination dose (RP2CD[s]) of the amivantamab and capmatinib combination therapy in ...

9. aetna.com aetna.com/cpb/medical/data/100_199/0190.html

Stem Cells for Hematopoietic Cell Transplant There is a lack of evidence regarding the safety and effectiveness of the Portomar access device. Currently, there is a clinical trial at the MD Anderson Cancer ...