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NCT Number: NCT05110989

A Multicenter Patient Registry on Outcomes From Cryoanalgesia of the Intercostal Nerves

This is a retrospective and prospective, multicenter, observational patient registry to record outcomes from patients undergoing cryoablation of the intercostal nerves (cryoanalgesia) for post-operative pain management.

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Key information

Conditions

Post Operative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Vienna, Vienna, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients whose age is 12 years or above, and are able to give informed consent/assent specific to state and national law.
  • Patients have been scheduled by physician(s) to undergo or have undergone cryoablation of the intercostal nerves utilizing at least one AtriCure device or are similar patients treated without the use of cryoablation

Exclusion criteria

  • Patient is enrolled in a concurrent trial that may impact the treatment offered by the registry devices.
  • Patient with exclusion criteria required by local governance.
  • Women of childbearing potential who are, or plan to become, pregnant during the time of the study

Treatment and study plan

AtriCure Cryo Nerve Block (cryoNB) Device Family

Device

Use of Atricure Cryo Nerve Block Device Family to generate cryoanalgesia for the management of post operative pain.

Primary outcomes

  1. Efficacy of cryo nerve block to generate cryoanalgesia as post operative pain management

    Time frame: From enrollment to 5 years after date of index procedure

    Collect pain score to assess the effect of cryoanalgesia effect with a follow up duration of up to 5 years.

  2. Safety of cryo nerve block to generate cryoanalgesia as post operative pain management

    Time frame: From enrollment to 5 years after date of index procedure

    Collect adverse events occurred during and post operation to assess the safety of the cryo nerve block procedure.

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth Menard

CONTACT

[email protected]

8327120715

Laura O'Brien, PhD

CONTACT

[email protected]

763-310-6151

Sponsors and collaborators

Lead sponsor

AtriCure, Inc.

Industry

Registry information

Official study title

The CryoICE™ Cryoanalgesia Registry for Pain Management in Post-cardiothoracic Surgery Via Cryoablation of the Intercostal Nerves

Acronym: REDUCE

Important dates

Study start
2018
Primary completion
2035
Study completion
2040
First posted
Nov 8, 2021
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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