Anastomotic LeakPhase 2NCT04582708
Use of NERv's Inline Device as an Early Diagnostic Method for Postoperative Complications
A Phase 2 study testing NERv's Inline Device in people with Anastomotic Leak and Fistula, run by FluidAI Medical at 7 sites in 3 countries.
Trial summary
NERv's traditional feasibility clinical trial is a multi-center, pre-market, single-arm, and non-randomized trial. This study will involve the retrospective analysis of prospectively collected data. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anastomotic Leak, Fistula, Postoperative Leak
- What is being tested?
- NERv's Inline Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 316 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 9 Nov 2020to 24 Sep 2024
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years - male or female
- Subject understands and has voluntarily signed and dated Informed Consent Form (ICF)
- Subjects must be willing to comply with trial requirements
- Subject has a peritoneal drain, such as Jackson Pratt drain attached post abdominal surgery
Who cannot join
- Plans that the subject will be discharged in less than 8 hours post-surgery
- Involvement in the planning and conduct of the clinical investigation
- Subject is participating in another investigational drug or device study which may interfere with the endpoints of this study
- NERv's Inline Device does not attach to drain used on the subject
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Canada5 sites
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
Juravinski Hospital- Hamilton Health Sciences
Hamilton, Ontrario, L8V 1C3
Grand River Hospital
Kitchener, Ontario, N2G 1G3
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
St. Joseph's Health Centre
Toronto, Ontario, M6R 1B5
About this study
Official title: Use of NERv's Inline Device for the Continuous Monitoring of pH and Conductivity as an Early Diagnostic Method for Postoperative Complications
NERv's traditional feasibility clinical trial is a multi-center, pre-market, single-arm, and non-randomized trial. This study will involve the retrospective analysis of prospectively collected data. The trial is intended to establish the safety of NERv's Inline Device and collect preliminary data to illustrate the change in pH and electrical conductivity during normal postoperative recovery and in the event of a complication.
The purpose of NERv's feasibility study is to establish a clinical model that shows the progressive change in pH and electrical conductivity during a normal post-operative recovery and in the event of an anastomotic leak in colorectal, hepatobiliary (HPB), trauma, and general surgery patients. Upon analyzing data collected from NERv's Inline Device, a clinical model of change in pH and conductivity over time will be created. The clinical model can be used in future stages to determine if a complication is developing. For instance, boundaries (reading thresholds) can be established to detect a complication when readings exceed such boundaries.
- Being tested
- NERv's Inline Device
- Medical subject headings
- Anastomotic Leak, Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NERv's Inline DeviceDevice
NERv's Inline Device is comprised of multiple sensors. It attaches in line to existing catheters or peritoneal drains that are currently approved for medical use. This allows the device to measure the pH and electrical conductivity of effluent fluids that are drained through peritoneal drains.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with NERv's Inline Device Attached | Experimental | This arm contains subjects which will have NERv's Inline Device attached to their peritoneal drain after abdominal surgery. Receives: Device: NERv's Inline Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pH of Peritoneal Fluid
NERv's Inline Device will be collecting continuous pH measurements of effluent fluid in abdominal surgery patients during normal recovery and in the event of a complication
Measured: A clinical model of change in pH over time will be established once the study is completed (up to 18 months)
Change in Electrical Conductivity of Peritoneal Fluid
NERv's Inline Device will be collecting continuous electrical conductivity measurements of effluent fluid in abdominal surgery patients during normal recovery and in the event of a complication
Measured: A clinical model of change in electrical conductivity over time will be established once the study is completed (up to 18 months)
Number of Subjects with Device Related Adverse Events
An adverse event assessment will be performed in accordance to ISO 14155 standards to determine the number of device related adverse events
Measured: The total number of device related adverse events will be established once the study is completed (up to 18 months)
Secondary outcomes (3)
Investigator Feedback on Device's Ease of Use
Ease of use and Impact on workflow will be evaluated by collecting responses to a questionnaire that will be filled out by the study team. The study team will evaluate the device's attachment, removal, setup, calibration, and their overall experience with the user interface on NERv's Mobile Application. The study team will be asked to rate their experience on a scale of 1-5, with 1 being very unsatisfied and 5 being very satisfied.
Measured: Ease of use and impact on workflow will be established once the study is completed (up to 18 months)
Subject Feedback on Device's Comfort level
Comfort level will be evaluated by collecting responses to a questionnaire that will be filled out by the subject. The subject will evaluate the device's weight, size, design, and their ability to sleep comfortably with the device attached. The subject will be asked to rate their experience on a scale of 1-5, with 1 being very unsatisfied and 5 being very satisfied.
Measured: Comfort level will be established once the study is completed (up to 18 months)
Estimate the economic benefit of the early detection of anastomotic leaks by contrasting the time of detection using NERv's Inline Device and Standard of Care
Retrospective data analysis will be performed to estimate the economic benefit of early detection of anastomotic leaks in patients undergoing gastrointestinal procedures by comparing the time of detection using NERv's Inline device and the time of detection using standard of care
Measured: The economic benefit of using NERv's Inline Device will be established once the study is completed (up to 18 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start9 Nov 2020
- Primary completion24 Sep 2024
- Study completion24 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anastomotic LeakStudies 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 316 participants (actual)
Sponsor and investigators
- Lead sponsor
- FluidAI Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04582708
- Sponsor's protocol ID
- CLS0006
- Status last verified
- Oct 2025
- First submitted
- 30 Sep 2020
- Last updated
- 10 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of NERv's Inline Device for the Continuous Monitoring of pH and Conductivity as an Early Diagnostic Method for Postoperative Complications
- ClinicalTrials.gov ID
- NCT04582708
- Acronym / sponsor ID
- CLS0006
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 316 participants (actual)
- Lead sponsor
- FluidAI MedicalIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 24 Sep 2024 (actual)
- Study completion
- 24 Sep 2024 (actual)
- First posted
- 9 Oct 2020 (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.
NERv's traditional feasibility clinical trial is a multi-center, pre-market, single-arm, and non-randomized trial. This study will involve the retrospective analysis of prospectively collected data. The trial is intended to establish the safety of NERv's Inline Device and collect preliminary data to illustrate the change in pH and electrical conductivity during normal postoperative recovery and in the event of a complication.
The purpose of NERv's feasibility study is to establish a clinical model that shows the progressive change in pH and electrical conductivity during a normal post-operative recovery and in the event of an anastomotic leak in colorectal, hepatobiliary (HPB), trauma, and general surgery patients. Upon analyzing data collected from NERv's Inline Device, a clinical model of change in pH and conductivity over time will be created. The clinical model can be used in future stages to determine if a complication is developing. For instance, boundaries (reading thresholds) can be established to detect a complication when readings exceed such boundaries.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with NERv's Inline Device Attached | Experimental | Device: NERv's Inline DeviceThis arm contains subjects which will have NERv's Inline Device attached to their peritoneal drain after abdominal surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years - male or female
- Subject understands and has voluntarily signed and dated Informed Consent Form (ICF)
- Subjects must be willing to comply with trial requirements
- Subject has a peritoneal drain, such as Jackson Pratt drain attached post abdominal surgery
Key exclusion criteria (4 listed)
- Plans that the subject will be discharged in less than 8 hours post-surgery
- Involvement in the planning and conduct of the clinical investigation
- Subject is participating in another investigational drug or device study which may interfere with the endpoints of this study
- NERv's Inline Device does not attach to drain used on the subject
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 |
|---|---|---|
| NERv's Inline DeviceNERv's Inline Device is comprised of multiple sensors. It attaches in line to existing catheters or peritoneal drains that are currently approved for medical use. This allows the device to measure the pH and electrical conductivity of effluent fluids that are drained through peritoneal drains. | Device | Subjects with NERv's Inline Device Attached |
Primary outcome
Change in pH of Peritoneal Fluid
Time frame: A clinical model of change in pH over time will be established once the study is completed (up to 18 months)
NERv's Inline Device will be collecting continuous pH measurements of effluent fluid in abdominal surgery patients during normal recovery and in the event of a complication
Change in Electrical Conductivity of Peritoneal Fluid
Time frame: A clinical model of change in electrical conductivity over time will be established once the study is completed (up to 18 months)
NERv's Inline Device will be collecting continuous electrical conductivity measurements of effluent fluid in abdominal surgery patients during normal recovery and in the event of a complication
Number of Subjects with Device Related Adverse Events
Time frame: The total number of device related adverse events will be established once the study is completed (up to 18 months)
An adverse event assessment will be performed in accordance to ISO 14155 standards to determine the number of device related adverse events
3 secondary outcomes
Investigator Feedback on Device's Ease of Use
Time frame: Ease of use and impact on workflow will be established once the study is completed (up to 18 months)
Subject Feedback on Device's Comfort level
Time frame: Comfort level will be established once the study is completed (up to 18 months)
Estimate the economic benefit of the early detection of anastomotic leaks by contrasting the time of detection using NERv's Inline Device and Standard of Care
Time frame: The economic benefit of using NERv's Inline Device will be established once the study is completed (up to 18 months)
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 10 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for Anastomotic Leak
Recruiting
Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area
Anastomotic Leaks, Hartmanns Stump Leakage
Recruiting
Prospective, Multicenter, Randomized Controlled Phase III Trial of Biological Mesh for Alimentary Tract Reconstruction in Digestive Surgery
Digestive System Surgical Procedures, Anastomosis, Surgical
Recruiting
Pre-emptive Endoscopic Vacuum Therapy Reduces the Incidence of Anastomotic Leakage After Colorectal Cancer Surgery
Colorectal Cancer, Colorectal Surgery
Not yet recruiting
FLuorescent Angiography in REduction of Anastomotic Leak in Rectal Cancer Surgery
Rectal Cancer Patients, Rectal Cancer Surgery
RecruitingObservational study
Surgical Intuition in Anastomotic Leakage After Colorectal Surgery
Anastomotic Leaks
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.
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NERv's Inline Device in people with Anastomotic Leak and Fistula, run by FluidAI Medical at 7 sites in 3 countries.
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 4 inclusion and 4 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 10 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada, United States, Saudi Arabia. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in pH of Peritoneal Fluid (time frame: A clinical model of change in pH over time will be established once the study is completed (up to 18 months)). The study lists 3 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 10 Oct 2025.