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Can oxygen therapy help fat grafts survive better in breast reconstruction?

NCT ID NCT07140198

Disease control Sponsor: University Hospital, Geneva Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether hyperbaric oxygen therapy (HBOT) can help transplanted fat survive longer in breast reconstruction after radiation treatment. Sixteen women who had radiation for breast cancer will each receive two fat grafting sessions—one with HBOT and one without—in a random order. MRI scans will measure how much fat remains after six months.

What this could mean

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

Active substance
hyperbaric oxygen therapy (HBOT)
What this could lead to
If it works, this could improve the success of fat grafting for breast reconstruction after radiation, leading to better cosmetic outcomes.
What could go wrong
This is a very small early-phase trial with only 16 patients, so results may not apply widely. HBOT also carries risks like ear or sinus pain and, rarely, lung injury.

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 16 people

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

Started

Mar 2026

Expected to finish

Dec 2028

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

Female participants only

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: * Adult (18 y.o. or more) female patients considered for lipofilling following breast reconstruction in an oncological setting which received radiation therapy on the affected breast. * Ability to provide informed consent, documented by signature Exclusion Criteria: * Pregnancy or breastfeeding * Unability to provide informed consent * Previous enrolment into the current investigation Contra-indication to HBOT : * Anamnestically reported spontaneous pneumothorax * Status post-thoracotomy * Significant intra-pulmonary lesions (including emphysematous bullae) * Respiratory function disorders (both obstructive and restrictive syndromes) * Pregnancy * Major psychiatric disorders * Uncontrollable claustrophobic reaction * Seizures, even if treated and asymptomatic for some time * Status post-severe traumatic brain injury with neurological deficits and seizures * Decompensated heart failure * Recent myocardial infarction (\<6 months) or with persistent hemodynamic sequelae * Spastic coronary angina * Cardiac arrhythmias, atrioventricular block, Wolff-Parkinson-White syndrome, sinus node dysfunction, Lown-Ganong-Levine syndrome * Cardiac pacemakers with unknown pressure resistance * Severe bradycardia * Sinus ostium displacement (acute or chronic) * Displacement of the auditory canal entrance (acute or chronic) * Status post-tympanoplasty type I-III \<3 months * Acute febrile state * Optic neuritis * Unstabilized hyperthyroidism Contra-indication to MRI : * Non-MRI-compatible pacemaker, cochlear implant, drug-infusion pump or neurostimulator. * Metallic foreign body in critical area (eye, brain, etc.) * Ferromagnetic vascular surgical clips of older generation, e.g., for intracranial aneurysm repair.

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Conditions

The condition(s) this trial relates to.

breast cancer

As listed by the trial registrant

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

Breast reconstruction Hyperbaric oxygen therapy Lipofilling

How to take part

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  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

  • Geneva University Hospitals

    RECRUITING

    Geneva, Canton of Geneva, 1206, Switzerland

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