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New optical device aims to detect dangerous neutropenia without needles

NCT ID NCT04448301

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a device called PointCheck that uses light to check for severe neutropenia (low white blood cells) in cancer patients without needing a blood sample. Researchers enrolled 81 adults with blood or breast cancers who were receiving chemotherapy. The main goal was to see how easy the device is to use, with a secondary look at how accurate it is. If it works well, it could allow patients to monitor their condition at home.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PointCheck device
What this could lead to
If successful, this could provide a simple, non-invasive way to monitor neutropenia at home, reducing the need for blood draws.
What could go wrong
This is a small, early usability study with only 81 participants. The device's accuracy is still being explored, and it may not be reliable enough for clinical use yet.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

81 people

The number who actually took part.

Started

Feb 2021

Finished

Jun 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Able to understand the purpose and risks of the study and to provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations. 2. Male or Female aged 18 years or above. 3. Diagnosed with a hematological (e.g., lymphoma, myeloma) or breast cancer. 4. Scheduled active treatment with cytotoxic chemotherapy with an associated high/intermediate risk of neutropenia. 5. Able (in the Investigators opinion) and willing to comply with all study requirements Exclusion Criteria 1. Participants with amputations, congenital malformations, or any severe abnormalities of the hands as determined by the investigator. 2. Participants with a history of vasculitis, Raynaud syndrome, scleroderma, mixed connective tissue disease or any other rheumatologic systemic condition that could produce microcirculatory changes in the nailfold. 3. Participants with circulating tumour cells in previous or current lab determinations. 4. Participants with leukemia. 5. Participants with any condition producing significant tremor (e.g., essential tremor, Parkinson´s disease, dystonic tremor). 6. Inadequately medically controlled hypotension (systolic blood pressure \<90 and diastolic blood pressure \< 60mmHg). 7. Participants whose gold standard blood differential was obtained more than 120 minutes after the last evaluation with the medical device. 8. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study. 9. Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the subject unsuitable for enrolment.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Boston Medical Center

    Boston, Massachusetts, 02118, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.