Use of NERv's Inline Device as an Early Diagnostic Method for Anastomotic Leak.

August 10, 2020 updated by: NERv Technology Inc

Use of NERv's Inline Device for the Continuous Monitoring of pH and Conductance Measurements as an Early Diagnostic Method for Anastomotic Leak.

NERv's early feasibility clinical trial is a first-in-human, multi-center, pre-market, non-randomized clinical trial intended to evaluate the safety and collect preliminary data necessary for the detection of clinical post-operative anastomotic/intraperitoneal leakages.

NERv's Inline Device attaches to existing catheters or peritoneal drains that are currently being used in the medical industry. This allows the device to measure the pH and conductance of intraperitoneal fluids that typically get drained through peritoneal drains.

The purpose of NERv's feasibility clinical trial is to collect pH and conductance readings by analyzing peritoneal drainage fluid. Upon analyzing data collected from NERv's Inline Device a clinical model of pH and conductance will be created. The clinical model can then be used to determine if a complication is developing. For instance, boundaries (reading thresholds) can be established where if the signal goes outside the boundaries a complication could be identified. Specifically the ability to detect a post-operative complication known as anastomotic leakage; which is a dreaded complication associated with abdominal surgeries; will be the main focus of the study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Cairo, Egypt
        • Assiut UNIVERSITY HOSPITAL
      • Cairo, Egypt
        • Dr. Yosri Gohar Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion 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 attached post-surgery

Exclusion Criteria:

  • Plans that the subject will be discharged 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 would interfere with the endpoints and follow-ups of this study
  • Subject is consuming steroid or anti-inflammatory medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DEVICE_FEASIBILITY
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Subjects with NERv's Inline Device Attached
This arm contains subjects which will have NERv's Inline Device attached to their peritoneal drain after bariatric surgery (this includes: Roux-en-Y Gastric Bypass (RYGBP), Sleeve Gastrectomy (SG), Gastric Plication and Duodenal Switch).
NERv's Inline Device attaches to existing catheters or peritoneal drains that are currently being used in the medical industry. This allows the device to measure the pH and conductance of intraperitoneal fluids that typically get drained through peritoneal drains.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 28 weeks).
NERv's Inline Device will be collecting continuous pH measurements of fluid that travels across the peritoneal drain of bariatric surgery patients.
A clinical model of change in pH over time will be established once the study is completed (up to 28 weeks).
Change in Conductance of Peritoneal Fluid
Time Frame: A clinical model of change in conductance over time will be established once the study is completed (up to 28 weeks).
NERv's Inline Device will be collecting continuous conductance measurements of fluid that travels across the peritoneal drain of bariatric surgery patients.
A clinical model of change in conductance over time will be established once the study is completed (up to 28 weeks).
Change in Temperature of Peritoneal Fluid
Time Frame: A clinical model of change in temperature over time will be established once the study is completed (up to 28 weeks).
NERv's Inline Device will be collecting continuous temperature measurements of fluid that travels across the peritoneal drain of bariatric surgery patients.
A clinical model of change in temperature over time will be established once the study is completed (up to 28 weeks).
Number of Subjects with Device Related Adverse Events
Time Frame: The number of device related will be established once the study is completed (up to 28 weeks).
an adverse event assesmtent will be performed in accordance to ISO 14155 standards to determine the number of device related adverse events.
The number of device related will be established once the study is completed (up to 28 weeks).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Investigator and Subject Feedback on Device's Ease of Use and Comfort level
Time Frame: Overall comfort level and ease of use will be established once the study is completed (up to 28 weeks).
Ease of use and comfort levels will be evaluated by collecting responses to a questionnaire that will be filled out by both the investigator/nurse and the subject.
Overall comfort level and ease of use will be established once the study is completed (up to 28 weeks).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 29, 2020

Primary Completion (ACTUAL)

March 15, 2020

Study Completion (ACTUAL)

March 15, 2020

Study Registration Dates

First Submitted

January 28, 2020

First Submitted That Met QC Criteria

January 31, 2020

First Posted (ACTUAL)

February 5, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 12, 2020

Last Update Submitted That Met QC Criteria

August 10, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • CLS0005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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