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

Study Overview
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Brief Summary
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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.

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

Conditions
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Anastomotic Leak

Intervention / Treatment
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* Device: NERv's Inline Device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects with NERv's Inline Device Attached<br>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). | Device: NERv's Inline Device<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | 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 | 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 | 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). |