Inflammatory ResponseNCT04171011
Nerve Stimulation During Esophagectomy
A study testing Stimulator device in people with Inflammatory Response, run by Galvani Bioelectronics at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Inflammatory Response
- What is being tested?
- Stimulator device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteNetherlands
- Study dates
- 28 Nov 2019to 6 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Splenic Nerve Stimulation During Esophagectomy
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.
Read the detailed description
Active dampening of the inflammatory response may be an important therapeutic target to decrease complications and improve recovery following esophagectomy. The current study is intended to evaluate the feasibility and safety of stimulating the exposed nerves in esophagectomy patients.
During minimally invasive esophagectomy, a neurovascular bundle (NVB) is exposed or partially exposed as part of the obligatory lymph node dissection. At the point in the esophagectomy when the NVB is being isolated, a lead will be applied laparoscopically to the NVB and connected to an external pulse generator. An ultrasound transducer will be introduced to the abdomen and placed on the NVB to visualize splenic arterial blood flow. The NVB will be stimulated while physiologic responses are observed. Blood samples will be taken before, and at certain pre-defined time points after, stimulation and recovery. The lead and ultrasound transducer will be removed after completion of stimulation, and the esophagectomy surgery will continue. Surgeon experience applying and removing the cuff electrode will be documented, in addition to the responses to NVB stimulation. Post-operative safety will be followed through 7-days (or day of discharge if earlier).
- Conditions
- Inflammatory Response
- Being tested
- Stimulator device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stimulator deviceDevice
The stimulator device will be used to electrically stimulate the NVB
| Study group | Role | What they receive |
|---|---|---|
| Nerve Stimulation | Experimental | Participants will undergo brief NVB stimulation during the esophagectomy procedure. Receives: Device: Stimulator device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility applying and removing the stimulation lead: Proportion of participants in whom the lead was successfully applied and removed
Proportion of participants in whom the lead was successfully applied and removed
Measured: 1 day
Safety of placement, stimulation and removal of the lead: Incidence of adverse events
Incidence of adverse events
Measured: 7 days
Secondary outcomes (3)
Peak Systolic Velocity (PSV) blood flow change measured by doppler ultrasound
Measured: Before stimulation and during stimulation
End Diastolic Velocity (EDV) blood flow change measured by doppler ultrasound
Measured: Before stimulation and during stimulation
Velocity Time Integral (VTI) blood flow change measured by doppler ultrasound
Measured: Before stimulation and during stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start28 Nov 2019
- Primary completion6 Oct 2020
- Study completion6 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory ResponseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galvani Bioelectronics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04171011
- Sponsor's protocol ID
- GAL1018
- Status last verified
- Oct 2020
- First submitted
- 18 Nov 2019
- Last updated
- 29 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Splenic Nerve Stimulation During Esophagectomy
- ClinicalTrials.gov ID
- NCT04171011
- Acronym / sponsor ID
- GAL1018
- Conditions
- Inflammatory Response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Galvani BioelectronicsIndustry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Study start
- 28 Nov 2019 (actual)
- Primary completion
- 6 Oct 2020 (actual)
- Study completion
- 6 Oct 2020 (actual)
- First posted
- 20 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Active dampening of the inflammatory response may be an important therapeutic target to decrease complications and improve recovery following esophagectomy. The current study is intended to evaluate the feasibility and safety of stimulating the exposed nerves in esophagectomy patients.
During minimally invasive esophagectomy, a neurovascular bundle (NVB) is exposed or partially exposed as part of the obligatory lymph node dissection. At the point in the esophagectomy when the NVB is being isolated, a lead will be applied laparoscopically to the NVB and connected to an external pulse generator. An ultrasound transducer will be introduced to the abdomen and placed on the NVB to visualize splenic arterial blood flow. The NVB will be stimulated while physiologic responses are observed. Blood samples will be taken before, and at certain pre-defined time points after, stimulation and recovery. The lead and ultrasound transducer will be removed after completion of stimulation, and the esophagectomy surgery will continue. Surgeon experience applying and removing the cuff electrode will be documented, in addition to the responses to NVB stimulation. Post-operative safety will be followed through 7-days (or day of discharge if earlier).
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nerve Stimulation | Experimental | Device: Stimulator deviceParticipants will undergo brief NVB stimulation during the esophagectomy procedure. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stimulator deviceThe stimulator device will be used to electrically stimulate the NVB | Device | Nerve Stimulation |
Primary outcome
Feasibility applying and removing the stimulation lead: Proportion of participants in whom the lead was successfully applied and removed
Time frame: 1 day
Proportion of participants in whom the lead was successfully applied and removed
Safety of placement, stimulation and removal of the lead: Incidence of adverse events
Time frame: 7 days
Incidence of adverse events
3 secondary outcomes
Peak Systolic Velocity (PSV) blood flow change measured by doppler ultrasound
Time frame: Before stimulation and during stimulation
End Diastolic Velocity (EDV) blood flow change measured by doppler ultrasound
Time frame: Before stimulation and during stimulation
Velocity Time Integral (VTI) blood flow change measured by doppler ultrasound
Time frame: Before stimulation and during stimulation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stimulator device in people with Inflammatory Response, run by Galvani Bioelectronics at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility applying and removing the stimulation lead: Proportion of participants in whom the lead was successfully applied and removed (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2020.