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

NCT ID: NCT05110989

Last Updated: 2025-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-29

Study Completion Date

2040-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Post Operative Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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AtriCure Cryo Nerve Block (cryoNB) Device Family

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patients whose age is 12 years or above, and are able to give informed consent/assent specific to state and national law.
2. 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

1. Patient is enrolled in a concurrent trial that may impact the treatment offered by the registry devices.
3. Women of childbearing potential who are, or plan to become, pregnant during the time of the study
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AtriCure, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Curits Quinn, MD

Role: PRINCIPAL_INVESTIGATOR

Elliot Hospital

Locations

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AdventHealth

Orlando, Florida, United States

Site Status RECRUITING

Henry Ford Health Rochester Hospital

Rochester, Michigan, United States

Site Status RECRUITING

St. Luke's Hospital of Kansas City

Kansas City, Missouri, United States

Site Status RECRUITING

Elliot Hospital

Manchester, New Hampshire, United States

Site Status RECRUITING

The Christ Hospital

Cincinnati, Ohio, United States

Site Status RECRUITING

Baylor College of Medicine

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Elizabeth Menard

Role: CONTACT

8327120715

Laura O'Brien, PhD

Role: CONTACT

763-310-6151

Facility Contacts

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Jessica Injiac

Role: primary

407-303-4265

Nicole Hensley

Role: primary

248-918-1973

Diane Peterman

Role: primary

816-932-5989

Curits Quinn, MD

Role: primary

Katherine Gloria

Role: primary

513-585-1777

Joan Reynoso Rosario, MD

Role: primary

713-798-6119

Other Identifiers

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REDUCE2018

Identifier Type: -

Identifier Source: org_study_id

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