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New treatment option for Breast Reconstruction
Official title Hyperbaric Oxygen Therapy to Improve Autologous Fat Graft Intake in Irradiated Breast
ClinicalTrials.gov ID: NCT07140198
What this study is testing
- What it's testing
- The goal of this clinical trial is to learn if hyperbaric oxygen therapy (HBOT) enhances fat graft survival in lipofilling procedures in irradiated breast cancer patients. The main questions it aims to answer are: Does it improve fat graft survival ?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Adult (18 y.o. or more) female patients considered for lipofilling following breast reconstruction in an oncological setting which received radiation...
- Ability to provide informed consent, documented by signature
You likely can't join if
- 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)
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Geneva, Canton of Geneva, Switzerland
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Geneva, Canton of Geneva, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.