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Nerve Stimulation During Esophagectomy

NCT04171011 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2020-10-29

No results posted yet for this study

Summary

Esophagectomy is the cornerstone for treatment of esophageal cancer. However, it is associated with substantial morbidity and mortality. Studies suggest that systemic inflammation after surgery has a negative impact on surgical outcomes. Attenuation of an excessive inflammatory response within the perioperative period for high-risk surgical procedures may reduce morbidity and mortality. The inflammatory response may be important in the development of these complications and reduction of inflammatory cytokine may be associated with an improved outcome.

The current study will evaluate the feasibility and safety of neuromodulation during minimally invasive surgery for esophageal cancer (esophagectomy) to assess impact on the inflammatory response. During the esophagectomy, a stimulation lead will be placed on the exposed nerves, and energy applied to the lead to test whether the nerves can be activated. The study will also measure potential physiological responses to nerve activation.

Conditions

  • Inflammatory Response

Interventions

DEVICE

Stimulator device

The stimulator device will be used to electrically stimulate the NVB

Sponsors & Collaborators

  • NAMSA

    collaborator OTHER

  • Galvani Bioelectronics

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-28
Primary Completion
2020-10-06
Completion
2020-10-06

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04171011 on ClinicalTrials.gov