NERv's Inline Device for Postoperative Complications

Recruiting at 6 trial locations

Overseen By Dr. Joao Rezende-Neto, MD, FRCSC, FACS, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: NERv Technology Inc

Disqualifiers: Discharge <8 hours, Other study, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

326 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults over 18 who've had abdominal surgery and have a peritoneal drain like a Jackson Pratt. Participants must follow the study rules and sign a consent form. It's not for those with incompatible drains, leaving the hospital within 8 hours post-surgery, involved in planning this study, or in another interfering study.

Inclusion Criteria

Subjects must be willing to comply with trial requirements

Subject understands and has voluntarily signed and dated Informed Consent Form (ICF)

I have a drain installed after abdominal surgery.

Exclusion Criteria

NERv's Inline Device does not attach to drain used on the subject

Involvement in the planning and conduct of the clinical investigation

I will be discharged within 8 hours after my surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Device Attachment and Monitoring

NERv's Inline Device is attached to the peritoneal drain to continuously monitor pH and electrical conductivity during postoperative recovery

Up to 18 months

Data Analysis

Retrospective analysis of collected data to establish a clinical model of change in pH and conductivity over time

Up to 18 months

Follow-up

Participants are monitored for safety and effectiveness after device removal

4 weeks

Treatment Details

Interventions

• NERv's Inline Device

Trial Overview The trial tests NERv's Inline Device to see if it can safely detect early signs of complications after surgery by monitoring changes in pH and electrical conductivity. The goal is to create a model that predicts complications from these readings.

Participant Groups

Group I: Subjects with NERv's Inline Device Attached Experimental Treatment 1 Intervention

This arm contains subjects which will have NERv's Inline Device attached to their peritoneal drain after abdominal surgery.

Who Is Running the Clinical Trial?

NERv Technology Inc

Lead Sponsor

Trials

2

Recruited

340+

FluidAI Medical

Lead Sponsor

Trials

5

Recruited

630+