ClinicalTrials.gg
RecruitingNCT06682208Updated Oct 8, 2026

ES Catheter vs Cryoablation After Pectus Surgery

An interventional study of ES catheter and Intercostal nerve cryoablation (INC) in Pectus Excavatum, sponsored by Children's Hospital Medical Center, Cincinnati. Recruiting at 1 site in United States. Open to participants aged 12 Years to 21 Years. Per ClinicalTrials.gov, last updated 2026-10-08.

Sponsored by Children's Hospital Medical Center, Cincinnati · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Apr 2024, registered Nov 2024).
  • Started Apr 2024; still recruiting 2 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
176
Allocation
Randomized
Ages
12 Years to 21 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Pectus Excavatum

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03

In context

Funnel Chest

79 studies on the registry are indexed under Funnel Chest; 10 are open to participants now.

This study's planned enrollment of 176 is above the median of 40 across 46 interventional studies indexed under Funnel Chest.

Browse Funnel Chest studies →

Lead sponsor

Children's Hospital Medical Center, Cincinnati is the lead sponsor of 673 studies on the registry; 130 are open to participants now.

Of its 57 completed or terminated interventional studies of FDA-regulated products, 31 (54%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 21 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 12 - 21 years
  • History of pectus excavatum
  • Scheduled for Nuss procedure

Exclusion criteria

Exclusion Criteria:

  • 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 with asymptomatic valvular lesions or defects may be included
  • >35
  • Pregnant or breastfeeding females
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
176 participants (estimated)

Study arms

  • Active comparator
    ES Catheter

    Hospital procedure for ES catheters will be followed for postoperative pain.

    Procedure: ES catheter

  • Active comparator
    Intercostal Nerve Cryoablation (INC)

    Hospital procedure for intercostal nerve cryoablation will be followed for postoperative pain.

    Procedure: Intercostal nerve cryoablation (INC)

Interventions

  • ProcedureES catheter

    ES catheter for postoperative pain control

  • ProcedureIntercostal nerve cryoablation (INC)

    INC used for postoperative pain control

06

What researchers measure

Primary outcomes

  1. Compare time to reach discharge

    Comparing physical therapy goals to meet discharge criteria.

    Time frame: Day of surgery up tp 10 days post-operative

Secondary outcomes

  1. Opioid consumption

    Comparing opioid consumption

    Time frame: Day of surgery to up to one year

  2. 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 1. \- lessened sensation 2. \- abnormal/painful sensation 3. \- no sensation

    Time frame: Day of surgery and post-operative day 1

  3. Neuropathic pain

    Surveys will be used to compare the incidence of neuropathic pain

    Time frame: Pre-operative, 6 weeks, 2-3 months, 4-6 months and 10-12 months post-operatively

07

Study locations

1 of 1 sites recruiting
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2024 (actual). Primary completion is estimated for Apr 2029, 60 months after the start.

Of 31 interventional studies with no phase under Funnel Chest, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 68. This study's planned 60 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 7, 2024
First posted
Nov 12, 2024
StartActual
Apr 8, 2024
Primary completionEst.
Apr 2029
CompletionEst.
Apr 2029
Last update
Oct 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date and oversight details
1 update, last Oct 8, 2026
Show all 1 update
  1. Oct 8, 2026
    Minor edits only
    + 2 other changes: verification date and oversight details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT06682208
Responsible party
Sponsor
First posted
Nov 12, 2024
Start date
Apr 8, 2024
Primary completion
Apr 2029 (estimated)
Completion
Apr 2029 (estimated)
Last update
Oct 8, 2026

Study contacts

Charlotte Walter, MD
Contact
Charlotte.Walter@cchmc.org
513-636-4408
Kristie Geisler, BS
Contact
Kristie.geisler@cchmc.org
513-636-3282
Charlotte Walter, MD
principal investigator · Children's Hospital Medical Center, Cincinnati
Surya Narayanasamy, MD
principal investigator · Children's Hospital Medical Center, Cincinnati

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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