Clinical trial NCT04253028: 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
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Anastomotic Leak
Lead sponsor: FluidAI Medical
Sponsor class: INDUSTRY
Collaborators: name: Unity Health Toronto
First posted: 2020-02-05
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.


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

Primary outcomes:
measure: Change in pH of Peritoneal Fluid
timeFrame: A clinical model of change in pH over time will be established once the study is completed (up to 28 weeks).
measure: Change in Conductance of Peritoneal Fluid
timeFrame: A clinical model of change in conductance over time will be established once the study is completed (up to 28 weeks).
measure: Change in Temperature of Peritoneal Fluid
timeFrame: A clinical model of change in temperature over time will be established once the study is completed (up to 28 weeks).
measure: Number of Subjects with Device Related Adverse Events
timeFrame: The number of device related will be established once the study is completed (up to 28 weeks).
Secondary outcomes:
measure: Investigator and Subject Feedback on Device's Ease of Use and Comfort level
timeFrame: Overall comfort level and ease of use will be established once the study is completed (up to 28 weeks).
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Assiut University Hospital
city: Cairo
country: Egypt
facility: Dr. Yosri Gohar Hospital
Study officials:
References: