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NERv's Inline Device for Postoperative Complications

Riyadh, Saudi Arabia

Phase 2

Waitlist Available

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

No Placebo-Only Group

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.

See full description

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

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I have a drain installed after abdominal surgery.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ comfort level will be established once the study is completed (up to 18 months)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Electrical Conductivity of Peritoneal Fluid

Change in pH of Peritoneal Fluid

Number of Subjects with Device Related Adverse Events

Secondary study objectives

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