NCT05153083

Cryoablation of Intercostal Nerves for Better Control of Postoperative Pain After Thoracic and Thoracoabdominal Open Surgery

Cryoablation of Intercostal Nerves for Better Control of Postoperative Pain After Thoracic and Thoracoabdominal Open Surgery - A Physician-initiated, International, Multicentre, Prospective, Observational Registry of Patients Undergoing Open Thoracic (TAA) and Thoracoabdominal Aortic Aneurysms Repair (TAAA) Using Cryoablation of Intercostal Nerves to Improve Postoperative Pain Control. (Cryo Registry)

• Status: Suspended
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Germano Melissano · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the registry is to evaluate the peri-operative and short- term outcomes of intercostal nerves cryoablation for post-operative pain control after open thoracic and thoracoabdominal aortic aneurysms repair. The cryoablation procedure is one of the opportunities for pain control after thoracotomy. So, it is routinely performed in major several centers in aortic surgery around the world as a part of the TAA and TAAA procedure. The Registry will include approximately 200 patients treated from January 2022 to January 2024 for thoracic or thoracoabdominal aortic aneurysm by means of open surgery and in whom intraoperative intercostal nerves cryoablation will be performed; to reach 200 patients, the enrolments can be extended until January 2027.

Conditions

• Aneurysm

Interventions

Type	Name	Description
PROCEDURE	Open thoracic (TAA) and thoracoabdominal aortic aneurysms repair (TAAA)	Each participating center will be able to use its preferred European Conformity marked device, for cryoablation according to their normal clinical practice and according to the instructions for use.

Timeline

• Start date: 2024-12-31
• Primary completion: 2025-12-31
• Completion: 2026-12-30
• First posted: 2021-12-10
• Last updated: 2025-05-02

Locations

13 sites across 8 countries: Austria, France, Germany, Italy, Netherlands, Portugal, Switzerland, United Kingdom