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

NCT04253028 | Completed Early Phase 1

• 1 other identifier: CLS0005
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

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.

Conditions

Anastomotic Leak

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Investigator and Subject Feedback on Device's Ease of Use and Comfort level

  Overall comfort level and ease of use will be established once the study is completed (up to 28 weeks).

Study Arms (1)

Subjects with NERv's Inline Device Attached

EXPERIMENTAL

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

Interventions

NERv's Inline Device 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.

Subjects with NERv's Inline Device Attached

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• FluidAI Medical: lead
• Unity Health Toronto: collaborator

Study Sites (2)

Assiut University Hospital

Cairo, Egypt

Location

Dr. Yosri Gohar Hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Anastomotic Leak

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2020
• First Posted: February 5, 2020
• Study Start: January 29, 2020
• Primary Completion: March 15, 2020
• Study Completion: March 15, 2020
• Last Updated: August 12, 2020

Record last verified: 2020-08

Locations

EG (2)