Cryoablation Effects on Acute and Chronic Pain After Thoracotomy and Thoracoscopy

NCT ID: NCT06384664

Last Updated: 2025-08-28

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

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-03

Study Completion Date

2028-04-30

Brief Summary

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The researchers will compare the common methods of post-surgical pain control, such as epidural or intercostal nerve block with a newer method called cryoablation. The research team is conducting this study to determine if cryoablation provides more effective pain control when compared to an epidural or intercostal nerve block.

Detailed Description

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Conditions

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Pain, Postoperative Intrathoracic Procedure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intercostal nerve block

Standard of care

Group Type ACTIVE_COMPARATOR

Standard of Care

Intervention Type PROCEDURE

An intercostal nerve block involves injecting anesthetic medications into nerves around the thoracic incision to provide temporary longer term pain relief after surgery.

Cryoablation

Cryoablation is a procedure that is used to freeze and burn away tissue cells via a device called a cryosphere which emits a freezing gas.

Group Type EXPERIMENTAL

Atricure's crysoSPHERE probe

Intervention Type DEVICE

Cryoablation is a procedure that is used to freeze and burn away tissue cells via a device called a cryosphere which emits a freezing gas.

Interventions

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Atricure's crysoSPHERE probe

Cryoablation is a procedure that is used to freeze and burn away tissue cells via a device called a cryosphere which emits a freezing gas.

Intervention Type DEVICE

Standard of Care

An intercostal nerve block involves injecting anesthetic medications into nerves around the thoracic incision to provide temporary longer term pain relief after surgery.

Intervention Type PROCEDURE

Other Intervention Names

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cryoablation Intercostal nerve block

Eligibility Criteria

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Inclusion Criteria

* Patients who could receive cryoablation in an elective open thoracic (posterolateral thoracotomy) or minimally invasive (thoracoscopy, including robotic) procedures at Michigan Medicine
* Patient is opioid naïve

Exclusion Criteria

* Patients who are pregnant
* Patients with cognitive impairment
* Patients with psychological disorders
* Patients with prior thoracic surgery
* Patients with fibromyalgia
* Patients with redo ipsilateral thoracic surgery
* Patients undergoing bilateral thoracotomy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AtriCure, Inc.

INDUSTRY

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Rishindra Reddy

Research Professor of Thoracic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rishindra Reddy, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Shari L Barnett

Role: CONTACT

734-936-4561

Facility Contacts

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Shari L Barnett

Role: primary

734-936-4561

Other Identifiers

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HUM00241242

Identifier Type: -

Identifier Source: org_study_id

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