- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04253028
Use of NERv's Inline Device as an Early Diagnostic Method for Anastomotic Leak.
Use of NERv's Inline Device for the Continuous Monitoring of pH and Conductance Measurements as an Early Diagnostic Method for Anastomotic Leak.
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.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
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Cairo, Egypt
- Assiut UNIVERSITY HOSPITAL
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Cairo, Egypt
- Dr. Yosri Gohar Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DEVICE_FEASIBILITY
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Subjects with NERv's Inline Device Attached
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).
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
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NERv's Inline Device will be collecting continuous pH measurements of fluid that travels across the peritoneal drain of bariatric surgery patients.
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A clinical model of change in pH over time will be established once the study is completed (up to 28 weeks).
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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).
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NERv's Inline Device will be collecting continuous conductance measurements of fluid that travels across the peritoneal drain of bariatric surgery patients.
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A clinical model of change in conductance over time will be established once the study is completed (up to 28 weeks).
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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).
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NERv's Inline Device will be collecting continuous temperature measurements of fluid that travels across the peritoneal drain of bariatric surgery patients.
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A clinical model of change in temperature over time will be established once the study is completed (up to 28 weeks).
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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).
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an adverse event assesmtent will be performed in accordance to ISO 14155 standards to determine the number of device related adverse events.
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The number of device related will be established once the study is completed (up to 28 weeks).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
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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.
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Overall comfort level and ease of use will be established once the study is completed (up to 28 weeks).
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLS0005
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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