Esophagectomy oesophageal surgery
Conditions
Interventions
Placement of a lead with a cuff electrode on the splenic NVB and stimulation of
these bundles
Sponsors
Galvani Bioelectronics
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * 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
Exclusion criteria
Exclusion criteria: * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the feasibility of an investigational lead to be temporarily applied to and removed from the NVB. Evaluate the safety of placement, stimulation and removal of the lead around the NVB. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess the impact of stimulation of the NVB on splenic blood flow. Assess the impact of stimulation of the NVB on cardiovascular parameters. Evaluate the impact of placement, stimulation, and removal of the lead around the NVB on the postoperative inflammatory response. | — |
Countries
Netherlands
Outcome results
None listed