Use of NERv's Inline Device as an Early Diagnostic Method for Anastomotic Leak.

FluidAI Medical

Status and phase: Completed; Early Phase 1

Conditions: Anastomotic Leak

Treatments: Device: NERv's Inline Device

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04253028

CLS0005

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Subjects with NERv's Inline Device Attached

Experimental group

Description:

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).

Treatment:

Device: NERv's Inline Device