Feasibility Study for Intrathoracic Nerve Stimulation

NCT04066374 | Completed Results FDA Device

• 1 other identifier: G190122
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to conduct an early clinical evaluation of safety and feasibility of peripheral nerve stimulation (PNS) of the intercostal nerves using an electrical lead placed in the thoracic cavity as a safe and effective method of pain control after cardiothoracic surgery.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (2)

• Pain as Measured by the Visual-analog Scale

  Pain level expressed by the study subject in the scale of 0 (no pain) to 10 (unbearable pain). Lower scores represent the better outcome.

  Baseline to 3 months

• Freedom From Device Related Adverse Events

  Freedom from device related adverse events (i.e., bleeding, infection, pneumothorax or arrhythmias)

  up to 7 days

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Intrathoracic placement of neurostimulation device

Device: Peripheral Nerve Stimulation

Interventions

Peripheral Nerve Stimulation DEVICE

Medtronic Intellis Spinal Cord Stimulation Device to be implanted in thoracic cavity to treat postoperative acute pain.

Also known as: Off-label use of Medtronic Intellis Spinal Cord Stimulation Device

Treatment Arm

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing pulmonary surgery by open thoracotomy or thoracoscopy with or without robotic assistance.

You may not qualify if:

• Woman who is pregnant,
• Subjects who have an active systemic infection or are immunocompromised,
• Subjects who will be exposed to diathermy or MRI,
• Subjects who have an electrically active implant, e.g., cardiac pacemaker, defibrillator, or neurostimulator,
• Subjects who are on anticoagulation therapy that would preclude their ability to undergo the implant procedure,
• Subjects less than 22 years of age,
• Subjects at elevated risk of infection or bleeding,
• Subjects unable to consent on their own,
• Subjects with active infection,
• Subjects with immunocompromised state,
• Subjects with preoperative chest pain,
• Subjects with pleural space infection or inflammatory process,
• Subjects undergoing esophageal, tracheal, or gastric procedures,
• Subjects undergoing pneumonectomy,
• Subjects with an uncorrectable coagulopathy,

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Yuki Kuramochi, BSN, RN
• Organization: Cleveland Clinic

kuramoy@ccf.org

216-445-4063

Study Officials

• Sudish Murthy, MD PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2019
• First Posted: August 26, 2019
• Study Start: August 13, 2019
• Primary Completion: January 9, 2024
• Study Completion: June 11, 2024
• Last Updated: July 9, 2024
• Results First Posted: July 9, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)