Feasibility of Splenic Nerve Stimulation During Esophagectomy
- Conditions
- Esophagectomyoesophageal surgery10017998
- Registration Number
- NL-OMON49161
- Lead Sponsor
- Galvani Bioelectronics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
* Female of non-reproductive potential or male
* Undergoing minimally invasive esophagectomy
* Confirmed presence of splenic NVB loop via imaging prior to surgery
* Age equal or above 21 years at the screening visit
* Capable of giving signed informed consent (IC)
* Normal blood pressure, or hypertensive managed with medication such that they
are deemed fit for surgery
* Previous splenectomy
* Existing implantable device
* Active pancreatitis or history of severe pancreatitis with complications,
hepatic or splenic disease
* Use of oral steroids 4 weeks prior to inclusion
* Current use immunosuppressive agents or biologicals. Previous use of
biologicals is allowed, if a washout period of 2 months is applied
* Use of anticoagulants within 1 week of surgery
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method