Status:
COMPLETED
Feasibility Study for Intrathoracic Nerve Stimulation
Lead Sponsor:
The Cleveland Clinic
Conditions:
Postoperative Pain
Eligibility:
All Genders
22+ years
Phase:
NA
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 th...
Detailed Description
Despite minimally invasive techniques in thoracic surgery, postoperative pain can still be an issue for patients. Achieving adequate pain control not only affects a patient's short and long term quali...
Eligibility Criteria
Inclusion
- • Patients undergoing pulmonary surgery by open thoracotomy or thoracoscopy with or without robotic assistance.
Exclusion
- 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,
- Subjects who are allergic or have shown hypersensitivity to any materials of the neurostimulation system which come in contact with the body.
Key Trial Info
Start Date :
August 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 11 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04066374
Start Date
August 13 2019
End Date
June 11 2024
Last Update
July 9 2024
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195