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NERv's Inline Device for Anastomotic Leak

Phase 2
Recruiting
Research Sponsored by NERv Technology Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject has a peritoneal drain, such as Jackson Pratt drain attached post abdominal surgery
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up comfort level will be established once the study is completed (up to 18 months)
Awards & highlights

Study Summary

This trial will help establish the safety of NERv's Inline Device and create a clinical model that could be used to detect post-operative complications.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this is an observational device trial focusing on safety and data collection rather than drug or invasive treatment, specific side effects are not detailed but may include discomfort or issues related to the attachment of the device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a drain installed after abdominal surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~comfort level will be established once the study is completed (up to 18 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and comfort level will be established once the study is completed (up to 18 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Electrical Conductivity of Peritoneal Fluid
Change in pH of Peritoneal Fluid
Number of Subjects with Device Related Adverse Events
Secondary outcome measures
Estimate the economic benefit of the early detection of anastomotic leaks by contrasting the time of detection using NERv's Inline Device and Standard of Care
Investigator Feedback on Device's Ease of Use
Subject Feedback on Device's Comfort level

Trial Design

1Treatment groups
Experimental Treatment
Group I: Subjects with NERv's Inline Device AttachedExperimental Treatment1 Intervention
This arm contains subjects which will have NERv's Inline Device attached to their peritoneal drain after abdominal surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NERv's Inline Device
2020
Completed Early Phase 1
~10

Find a Location

Who is running the clinical trial?

NERv Technology IncLead Sponsor
1 Previous Clinical Trials
9 Total Patients Enrolled
1 Trials studying Anastomotic Leak
9 Patients Enrolled for Anastomotic Leak
FluidAI MedicalLead Sponsor
2 Previous Clinical Trials
224 Total Patients Enrolled
2 Trials studying Anastomotic Leak
224 Patients Enrolled for Anastomotic Leak

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Use of NERv's Inline Device as an Early Diagnostic Method for Postoperative Complications
2020. "Use of NERv's Inline Device as an Early Diagnostic Method for Postoperative Complications". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04582708.
~22 spots leftby Aug 2024
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