CompletedPhase 2

Use of NERv's Inline Device as an Early Diagnostic Method for Postoperative Complications

United States, Canada, Saudi Arabia316 participantsStarted 2020-11-09

Plain-language summary

NERv's traditional feasibility clinical trial is a multi-center, pre-market, single-arm, and non-randomized trial. This study will involve the retrospective analysis of prospectively collected data. The trial is intended to establish the safety of NERv's Inline Device and collect preliminary data to illustrate the change in pH and electrical conductivity during normal postoperative recovery and in the event of a complication. The purpose of NERv's feasibility study is to establish a clinical model that shows the progressive change in pH and electrical conductivity during a normal post-operative recovery and in the event of an anastomotic leak in colorectal, hepatobiliary (HPB), trauma, and general surgery patients. Upon analyzing data collected from NERv's Inline Device, a clinical model of change in pH and conductivity over time will be created. The clinical model can be used in future stages to determine if a complication is developing. For instance, boundaries (reading thresholds) can be established to detect a complication when readings exceed such boundaries.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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, such as Jackson Pratt drain attached post abdominal surgery Exclusion Criteria: * Plans that the subject will be discharged in 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 may interfere with the endpoints of this study * NERv's Inline Device does not attach to drain used on the subject

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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 18 months)

Change in Electrical Conductivity of Peritoneal Fluid

Timeframe: A clinical model of change in electrical conductivity over time will be established once the study is completed (up to 18 months)

Number of Subjects with Device Related Adverse Events

Timeframe: The total number of device related adverse events will be established once the study is completed (up to 18 months)

Trial details

NCT IDNCT04582708

SponsorFluidAI Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-09-24

View on ClinicalTrials.gov More Anastomotic Leak trials