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Compares treatment options for Pectus Excavatum
Official title ES Catheter vs Cryoablation After Pectus Surgery
ClinicalTrials.gov ID: NCT06682208
What this study is testing
- What it's testing
- Participants will be randomized to receive ES catheter or cryoablation for pain management after the Nuss procedure. The goal of this study is to compare the following between the two groups: Time to achieve short-term physical therapy goals and long-term functional outcomes Compare immediate and long-term postoperative opioid use Compare numbness on chest of postoperative day 1 and the return of sensation to baseline Compare the incidence of neuropathic pain and other complications Participants will receive surveys for up to 12 months postoperatively.
- Time commitment: about 12 months
- 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 12 to 21
You may be able to join if
- Age 12 - 21 years
- History of pectus excavatum
- Scheduled for Nuss procedure
You likely can't join if
- Prior pectus repair
- Other concomitant surgeries
- Chronic pain conditions including Ehlers Danlos Syndrome
- Non-English speaking - rationale: the questionnaires used in the study are in English language and the social and cultural factors of pain perception...
- Severe developmental delays including cognitive (difficulties understanding), motor (cerebral palsy or muscular dystrophy), and speech delays...
- History of or active renal or liver disease
See the full eligibility criteria
- Age 12 - 21 years
- History of pectus excavatum
- Scheduled for Nuss procedure
- Prior pectus repair
- Other concomitant surgeries
- Chronic pain conditions including Ehlers Danlos Syndrome
- Non-English speaking - rationale: the questionnaires used in the study are in English language and the social and cultural factors of pain perception of non-English speaking patients could affect the study power
- Severe developmental delays including cognitive (difficulties understanding), motor (cerebral palsy or muscular dystrophy), and speech delays (difficulties communicating)
- History of or active renal or liver disease
- Major surgery requiring opioids in the last 2 years
- Severe respiratory problems (such as obstructive sleep apnea, cystic fibrosis, pulmonary fibrosis, or pneumonia within the last month)
- Cardiac conditions including, but not limited to, cyanotic heart disease, hypoplastic left ventricle, arrhythmia, uncontrolled hypertension with ongoing treatment, Kawasaki disease, or cardiomyopathies. Participants...
- BMI \>35
- Pregnant or breastfeeding females
The study team makes the final eligibility decision.
Where it's taking place
- Cincinnati, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cincinnati, Ohio, United States. 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.