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Can a catheter in bone tell surgeons if a graft is healthy?

NCT ID NCT01879384

Knowledge-focused Sponsor: Centre Hospitalier Universitaire, Amiens Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested whether a small microdialysis catheter placed directly into a bone graft could monitor blood flow and healing after head and neck reconstruction. Thirty-four people having surgery with bone from their hip or leg took part. The goal was to see if the catheter could reliably measure key chemicals in the bone tissue.

What this could mean

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

Active substance
CMA 70 microdialysis catheter (device placed in bone tissue)
What this could lead to
If successful, this method could give surgeons a reliable way to check if bone grafts are healing properly after head and neck reconstruction.
What could go wrong
This is a small feasibility study with only 34 participants, so results may not apply widely. The catheter placement is experimental and may not always work.

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

34 people

The number who actually took part.

Start date

Feb 2011

Finished

Jun 2013

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: * head and neck reconstruction with iliac crest or fibula free flaps * informed consent obtained Exclusion Criteria: * reconstruction with other types of free flaps

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Conditions

The condition(s) this trial relates to.

head and neck cancer Head and Neck Neoplasms head injury

As listed by the trial registrant

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

Bone free flap Head and neck cancer Head and neck reconstructive surgery Head and/or neck shotgun trauma Microsurgery

Contacts and locations

Locations

  • Amiens University Hospital

    Amiens, Picardie, 80054, France

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