Use of NERv's Inline Device as an Early Diagnostic Method for Anastomotic Leak.
Primary Purpose
Anastomotic Leak
Status
Completed
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
NERv's Inline Device
Sponsored by
About this trial
This is an interventional device feasibility trial for Anastomotic Leak
Eligibility Criteria
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
Sites / Locations
- Assiut University Hospital
- Dr. Yosri Gohar Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Subjects with NERv's Inline Device Attached
Arm Description
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).
Outcomes
Primary Outcome Measures
Change in pH of Peritoneal Fluid
NERv's Inline Device will be collecting continuous pH measurements of fluid that travels across the peritoneal drain of bariatric surgery patients.
Change in Conductance of Peritoneal Fluid
NERv's Inline Device will be collecting continuous conductance measurements of fluid that travels across the peritoneal drain of bariatric surgery patients.
Change in Temperature of Peritoneal Fluid
NERv's Inline Device will be collecting continuous temperature measurements of fluid that travels across the peritoneal drain of bariatric surgery patients.
Number of Subjects with Device Related Adverse Events
an adverse event assesmtent will be performed in accordance to ISO 14155 standards to determine the number of device related adverse events.
Secondary Outcome Measures
Investigator and Subject Feedback on Device's Ease of Use and Comfort level
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.
Full Information
NCT ID
NCT04253028
First Posted
January 28, 2020
Last Updated
August 10, 2020
Sponsor
FluidAI Medical
Collaborators
Unity Health Toronto
1. Study Identification
Unique Protocol Identification Number
NCT04253028
Brief Title
Use of NERv's Inline Device as an Early Diagnostic Method for Anastomotic Leak.
Official Title
Use of NERv's Inline Device for the Continuous Monitoring of pH and Conductance Measurements as an Early Diagnostic Method for Anastomotic Leak.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
January 29, 2020 (Actual)
Primary Completion Date
March 15, 2020 (Actual)
Study Completion Date
March 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
FluidAI Medical
Collaborators
Unity Health Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anastomotic Leak
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subjects with NERv's Inline Device Attached
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
NERv's Inline Device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in pH of Peritoneal Fluid
Description
NERv's Inline Device will be collecting continuous pH measurements of fluid that travels across the peritoneal drain of bariatric surgery patients.
Time Frame
A clinical model of change in pH over time will be established once the study is completed (up to 28 weeks).
Title
Change in Conductance of Peritoneal Fluid
Description
NERv's Inline Device will be collecting continuous conductance measurements of fluid that travels across the peritoneal drain of bariatric surgery patients.
Time Frame
A clinical model of change in conductance over time will be established once the study is completed (up to 28 weeks).
Title
Change in Temperature of Peritoneal Fluid
Description
NERv's Inline Device will be collecting continuous temperature measurements of fluid that travels across the peritoneal drain of bariatric surgery patients.
Time Frame
A clinical model of change in temperature over time will be established once the study is completed (up to 28 weeks).
Title
Number of Subjects with Device Related Adverse Events
Description
an adverse event assesmtent will be performed in accordance to ISO 14155 standards to determine the number of device related adverse events.
Time Frame
The number of device related will be established once the study is completed (up to 28 weeks).
Secondary Outcome Measure Information:
Title
Investigator and Subject Feedback on Device's Ease of Use and Comfort level
Description
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.
Time Frame
Overall comfort level and ease of use will be established once the study is completed (up to 28 weeks).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Assiut University Hospital
City
Cairo
Country
Egypt
Facility Name
Dr. Yosri Gohar Hospital
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Use of NERv's Inline Device as an Early Diagnostic Method for Anastomotic Leak.
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