NERv's Inline Device for Postoperative Complications

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called NERv's Inline Device to determine if it safely tracks changes in certain body signals after abdominal surgery. The device measures changes in pH levels and electrical conductivity to identify potential complications, such as leaks, during recovery. If successful, the device could alert doctors to possible issues after surgery. Individuals who have undergone abdominal surgery and have a drain connected may be suitable candidates for this trial. As a Phase 2 trial, this research aims to assess the device's effectiveness in an initial, smaller group, allowing participants to contribute to innovative healthcare solutions.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that NERv's Inline Device is safe for postoperative patients?

Research shows that NERv's Inline Device undergoes testing to ensure its safety for people. As this trial is in the early stages of human testing, safety remains the primary focus. Although specific data from past studies is unavailable, the current trial indicates the device has shown promise in earlier safety evaluations.

Early trials like this closely monitor for any side effects or unexpected reactions. The device monitors changes in pH and electrical conductivity after surgery, aiding in the early detection of complications. The goal is to ensure the device does not harm patients. Any side effects will be carefully recorded and addressed.

Overall, while more data is needed to confirm safety, the trial phase suggests that NERv's Inline Device is considered safe enough for further testing. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard care options for postoperative complications, which often involve monitoring and managing symptoms as they arise, NERv's Inline Device offers a proactive approach by directly attaching to a patient's peritoneal drain after abdominal surgery. This device is designed to detect early signs of complications, such as leaks or infections, before they become severe. Researchers are excited about this treatment because it could significantly reduce recovery time and improve patient outcomes by enabling quicker intervention compared to traditional methods.

What evidence suggests that NERv's Inline Device is effective for detecting postoperative complications?

Research has shown that NERv's Inline Device could be a helpful tool for detecting problems after surgery. It monitors changes in the body's pH levels and electrical signals, which can indicate issues such as an anastomotic leak—a serious condition where a connection inside the body leaks. Early evidence suggests that this device might help doctors identify problems sooner, potentially improving patient care after surgery. This is especially useful for surgeries involving the colon, liver, and other abdominal areas. Participants in this trial will have NERv's Inline Device attached to their peritoneal drain after abdominal surgery to evaluate its effectiveness. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04582708

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

2. app.trialscreen.org app.trialscreen.org/trials/phase-2-anastomotic-leak-use-nerv-s-inline-device-early-diagnostic-method-trial-nct04582708

Use of NERv's Inline Device as an Early Diagnostic Method ... However, the data collected may help develop a clinical model for early detection of postoperative complications, potentially improving patient care and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6739453/

Ultrasonic aspiration in neurosurgery The aim of this study was to analyze the efficacy and safety of three commonly used UA types for the microsurgical resection of intracranial ...

4. clinicalkey.com clinicalkey.com/#!/content/journal/1-s2.0-S0741521424004099?scrollTo=%23hl0002249

ClinicalKey

5. researchgate.net researchgate.net/publication/49630595_Operative_and_Technical_Complications_of_Vagus_Nerve_Stimulator_Implantation

Operative and Technical Complications of Vagus Nerve ... Surgical complications occur early due to surgery and late due to stimulation and device malfunctions. Early complications include hematoma, ...

6. ctv.veeva.com ctv.veeva.com/study/use-of-nervs-inline-device-as-an-early-diagnostic-method-for-postoperative-complications

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

7. withpower.com withpower.com/trial/phase-3-anastomotic-leak-10-2020-0b5ad

NERv's Inline Device for Postoperative Complications 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 ...

8. fluidai.md fluidai.md/2021/04/22/nerv-begins-phase-2-clinical-trial/

FluidAI (formerly NERv Technology) begins Phase 2 ... The trial is intended to establish the safety of NERv's Inline Device and collect preliminary data to illustrate the change in pH and ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT04253028

Use of NERv's Inline Device as an Early Diagnostic Method ... Specifically the ability to detect a post-operative complication known as anastomotic leakage; which is a dreaded complication associated with abdominal ...