Study Description

•  Brief 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. 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.

Condition or disease	Intervention/Treatment	Phase
Anastomotic Leak	Device: NERv’s Inline Device	Phase 2

Study Design

Study Type: Interventional (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Use of NERv’s Inline Device for the Continuous Monitoring of pH and Conductivity as an Early Diagnostic Method for Postoperative Complications
Actual Study Start Date : November 9, 2020
Estimated Primary Completion Date : February 15, 2022
Estimated Study Completion Date : February 15, 2022

    Resource links provided by the National Library of Medicine.

MedlinePlus related topics: After Surgery

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Subjects with NERv’s Inline Device AttachedThis arm contains subjects which will have NERv’s Inline Device attached to their peritoneal drain after abdominal surgery.	Device: 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.

Outcome Measures

• Primary Outcome Measures:
  1. 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
  2. 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
  3. 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

• Secondary Outcome Measures:
  1. 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) ]
     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.
  2. Subject Feedback on Device’s Comfort level [ Time Frame: Comfort level will be established once the study is completed (up to 18 months) ]
     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.
  3. 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) ]
     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

Eligibility Criteria

Information from the National Library of Medicine 

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

• CriteriaInclusion Criteria:
  • 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
  Exclusion Criteria:
  • 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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04582708

• Contacts Contact: Dr. Joao Rezende-Neto, MD, FRCSC, FACS, PhD 4168646060 ext 5284, RezendeNetoJ@smh.ca
• Locations United States, OhioCleveland ClinicNot yet recruitingCleveland, Ohio, United States, 44195Contact: Emre Gorgun, MD, FACS, FASCRS    (216) 444-1244    GORGUNE@ccf.orgCanada, OntarioSt. Michael’s HospitalRecruitingToronto, Ontario, Canada, M5B 1W8Contact: Joao Rezende-Neto, MD, FRCSC, FACS, PhD    (416) 864-6060 ext 5284    Joao.Rezende-Neto@unityhealth.toSt. Joseph’s Health CentreNot yet recruitingToronto, Ontario, Canada, M6R 1B5Contact: Shiva Jayaraman, MD, MESc, FRCSC    (416) 530-6653    Shiva.Jayaraman@unityhealth.toCanada, OntrarioJuravinski Hospital- Hamilton Health SciencesRecruitingHamilton, Ontrario, Canada, L8V 1C3Contact: Pablo E Serrano, MD, MPH, FACS    (905) 521-2100 ext 43872    serrano@mcmaster.ca

Sponsors and Collaborators

• NERv Technology Inc

More Information

Responsible Party: NERv Technology Inc
ClinicalTrials.gov Identifier: NCT04582708, History of Changes
Other Study ID Numbers: CLS0006
First Posted: October 9, 2020, Key Record Dates
Last Update Posted: April 22, 2021
Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

• Postoperative Complications
• Anastomotic Leak
• Pathologic Processes