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Wearable patch could keep tabs on spine surgery patients without wires

NCT ID NCT07105189

Knowledge-focused Sponsor: Rigshospitalet, Denmark Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 10, 2026 · Updated 3 times

Summary

This study tests a wearable chest patch that continuously measures heart rate, breathing, oxygen levels, blood pressure, and temperature in patients recovering from major spinal surgery. Researchers want to see if nurses and patients find the device easy and useful compared to standard spot checks. The study will enroll 150 adults and follow them during their hospital stay.

What this could mean

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

Active substance
CPC12S wearable sensor (chest electrodes measuring ECG, heart rate, respiratory rate, SpO2, blood pressure, temperature)
What this could lead to
If successful, this could show that wireless monitoring is practical and liked by nurses, possibly leading to earlier detection of complications after spinal surgery.
What could go wrong
This is a small feasibility study, not a large trial. It focuses on nurse and patient acceptance, not on proving that monitoring improves health outcomes. The device may have technical issues or not be widely adopted.

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

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * Included are adult patients (\>=18 years) scheduled for ASD surgery with estimated a \>3 day expected post-operative stay. ASD-surgery is defined as a posterior instrumented fusion of at least five spinal levels including instrumentation to the pelvis, caused by a degenerative condition of the spine. * Registered nurses and nurses' assistants employed at the orthopedic ward during the study period will be included if they have experience working with wCVSM during the study period. The study includes both sexes, variation of level of education and years of work experience. Included nurses and nurses' assistants should be proficient in the Danish language. Exclusion Criteria: * Exclusion criteria are patients who are unable to wear continuous monitoring due to a pacemaker or allergy. * Patients who are not proficient in the Danish language will be excluded.

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Conditions

The condition(s) this trial relates to.

vertebral column disorder

As listed by the trial registrant

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

Acceptability Adult spinal deformity Asd surgery Feasibility studies Remote monitoring Wireless continuous vital signs monitoring Wireless vital signs monitoring system

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Department of Bone and Joint surgery, University hospital, Rigshospitalet, Copenhagen

    RECRUITING

    Copenhagen, 2100, Denmark

More trials for these conditions

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