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

Anastomotic Leak Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04253028
• Other study ID #: CLS0005
• Status: Completed
• Phase: Early Phase 1
• Start date: January 29, 2020
• Est. completion date: March 15, 2020

Study information

• Verified date: August 2020
• Source: NERv Technology Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: March 15, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anastomotic Leak

Intervention

Device:
• NERv's Inline Device
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.

Locations

Country	Name	City	State
Egypt	Assiut University Hospital	Cairo
Egypt	Dr. Yosri Gohar Hospital	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
NERv Technology Inc	St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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).
Primary	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).
Primary	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	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).