Pectus ExcavatumNCT06682208
ES Catheter vs Cryoablation After Pectus Surgery
A study testing ES catheter and Intercostal nerve cryoablation (INC) in people with Pectus Excavatum, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 12 to 21 years
- Conditions the study is for
- Pectus Excavatum
- What is being tested?
- ES catheter and Intercostal nerve cryoablation (INC)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2024to Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 12 - 21 years
- History of pectus excavatum
- Scheduled for Nuss procedure
Who cannot join
- 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
Show all 11Show fewer
- 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 with asymptomatic valvular lesions or defects may be included
- BMI >35
- Pregnant or breastfeeding females
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Charlotte Walter, MD, 513-636-4408, charlotte.walter@cchmc.org
Kristie Geisler, BS, 513-636-3282, kristie.geisler@cchmc.org
About this study
Official title: Prospective Randomized Trial of Efficacy and Safety of Erector Spinae Catheter and Intercostal Nerve Cryoablation Protocols After Pectus Surgery
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.
- Conditions
- Pectus Excavatum
- Being tested
- ES catheter, Intercostal nerve cryoablation (INC)
- Medical subject headings
- Funnel Chest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ES catheterProcedure or surgery
ES catheter for postoperative pain control
Intercostal nerve cryoablation (INC)Procedure or surgery
INC used for postoperative pain control
| Study group | Role | What they receive |
|---|---|---|
| ES Catheter | Active comparator | Hospital procedure for ES catheters will be followed for postoperative pain. Receives: Procedure: ES catheter |
| Intercostal Nerve Cryoablation (INC) | Active comparator | Hospital procedure for intercostal nerve cryoablation will be followed for postoperative pain. Receives: Procedure: Intercostal nerve cryoablation (INC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare time to reach discharge
Comparing physical therapy goals to meet discharge criteria.
Measured: Day of surgery up tp 10 days post-operative
Secondary outcomes (3)
Opioid consumption
Comparing opioid consumption
Measured: Day of surgery to up to one year
Numbness on chest
An exam glove with ice will used on the anterior axillary line to obtain a rating of the sensation felt.
0 - no sensation
- - lessened sensation
- - abnormal/painful sensation
- - no sensation
Measured: Day of surgery and post-operative day 1
Neuropathic pain
Surveys will be used to compare the incidence of neuropathic pain
Measured: Pre-operative, 6 weeks, 2-3 months, 4-6 months and 10-12 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start8 Apr 2024
- Primary completionApr 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pectus ExcavatumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charlotte Walter, MD, Principal investigator, Children's Hospital Medical Center, CincinnatiSurya Narayanasamy, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06682208
- Sponsor's protocol ID
- 2022-0760
- Status last verified
- Oct 2026
- First submitted
- 7 Nov 2024
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial of Efficacy and Safety of Erector Spinae Catheter and Intercostal Nerve Cryoablation Protocols After Pectus Surgery
- ClinicalTrials.gov ID
- NCT06682208
- Acronym / sponsor ID
- 2022-0760
- Conditions
- Pectus Excavatum
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ES Catheter | Active comparator | Procedure: ES catheterHospital procedure for ES catheters will be followed for postoperative pain. |
| Intercostal Nerve Cryoablation (INC) | Active comparator | Procedure: Intercostal nerve cryoablation (INC)Hospital procedure for intercostal nerve cryoablation will be followed for postoperative pain. |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age 12 - 21 years
- History of pectus excavatum
- Scheduled for Nuss procedure
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ES catheterES catheter for postoperative pain control | Procedure or surgery | ES Catheter |
| Intercostal nerve cryoablation (INC)INC used for postoperative pain control | Procedure or surgery | Intercostal Nerve Cryoablation (INC) |
Primary outcome
Compare time to reach discharge
Time frame: Day of surgery up tp 10 days post-operative
Comparing physical therapy goals to meet discharge criteria.
3 secondary outcomes
Opioid consumption
Time frame: Day of surgery to up to one year
Numbness on chest
Time frame: Day of surgery and post-operative day 1
Neuropathic pain
Time frame: Pre-operative, 6 weeks, 2-3 months, 4-6 months and 10-12 months post-operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Charlotte Walter, MD principal investigator
Children's Hospital Medical Center, Cincinnati
Surya Narayanasamy, MD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ES catheter and Intercostal nerve cryoablation (INC) in people with Pectus Excavatum, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charlotte Walter, MD (513-636-4408, Charlotte.Walter@cchmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare time to reach discharge (time frame: Day of surgery up tp 10 days post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.