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.

Condition or disease	Intervention/treatment	Phase
Anastomotic Leak	Device: NERv’s Inline Device	Early Phase 1

Study Design

Study Type: Interventional (Clinical Trial)
Actual Enrollment: 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
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.
Actual Study Start Date : January 29, 2020
Actual Primary Completion Date : March 15, 2020
Actual Study Completion Date : March 15, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Subjects with NERv’s Inline Device AttachedThis 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 DeviceNERv’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.

Outcome Measures

• Primary Outcome Measures:
  1. Change in pH of Peritoneal Fluid [ Time Frame: A clinical model of change in pH over time will be established once the study is completed (up to 28 weeks). ]
     NERv’s Inline Device will be collecting continuous pH measurements of fluid that travels across the peritoneal drain of bariatric surgery patients.
  2. Change in Conductance of Peritoneal Fluid [ Time Frame: A clinical model of change in conductance over time will be established once the study is completed (up to 28 weeks). ]
     NERv’s Inline Device will be collecting continuous conductance measurements of fluid that travels across the peritoneal drain of bariatric surgery patients.
  3. Change in Temperature of Peritoneal Fluid [ Time Frame: A clinical model of change in temperature over time will be established once the study is completed (up to 28 weeks). ]
     NERv’s Inline Device will be collecting continuous temperature measurements of fluid that travels across the peritoneal drain of bariatric surgery patients
  4. Number of Subjects with Device Related Adverse Events [ Time Frame: The number of device related will be established once the study is completed (up to 28 weeks). ]
     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:
  1. Investigator and Subject Feedback on Device’s Ease of Use and Comfort level [ Time Frame: Overall comfort level and ease of use will be established once the study is completed (up to 28 weeks). ]
     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.

Eligibility Criteria

Information from the National Library of Medicine 

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Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes

• CriteriaInclusion 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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04253028

• Locations
  
  Egypt
  
  Assiut University Hospital
  Cairo, EgyptDr. Yosri Gohar Hospital
  Cairo, Egypt
• Sponsors and Collaborators
  NERv Technology Inc
  Unity Health Toronto

More Information

Responsible Party: NERv Technology Inc
ClinicalTrials.gov Identifier: NCT04253028, History of Changes
Other Study ID Numbers: CLS0005
First Posted: February 5, 2020, Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: August 2020

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

• Anastomotic Leak
• Postoperative Complications
• Pathologic Processes