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Non-invasive continuous remote monitoring with structured escalation pathway for Ileostomy

N/A

Waitlist Available

Led By Nirav S Shah

Research Sponsored by NorthShore University HealthSystem

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average 2 year

Awards & highlights

Study Summary

This trial is testing a wearable solution that predicts physiological problems and sends alerts to surgeons and nurses in order to improve care for patients after high-risk colorectal surgery.

Eligible Conditions

Ileostomy

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average 2 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average 2 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average 2 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adherence to study requirement rate

Attrition rate

Enrollment rate

Secondary outcome measures

Documented Dietary counseling

Documented Medication adherence counseling

Stool regimen escalation

Trial Design

2Treatment groups

Experimental Treatment

Group I: Soft LaunchExperimental Treatment2 Interventions

The study will include ten eligible patients into the soft launch to test and reconfigure workflow, protocol, alerting structure and other operation related factors.

Group II: PilotExperimental Treatment2 Interventions

After the soft launch, the study will include 45 eligible patients into the pilot to conduct the rest of the study

Do I qualify?Apply below to find out

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Who is running the clinical trial?

NorthShore University HealthSystemLead Sponsor

132 Previous Clinical Trials

737,805 Total Patients Enrolled

Nirav S ShahPrincipal InvestigatorNorthShore University HealthSystem

1 Previous Clinical Trials

43 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment in need of more participants?

"Affirmative. According to records published on clinicaltrials.gov, this research trial is actively recruiting participants; commencing enrollment on August 9th 2021 and revised lastly December 9th 2021. It specifies that it requires 55 individuals from 3 different medical locations."

Answered by AI

Is this trial open to those aged seventy-five and above?

"This medical study requires participants to be aged between 18-100 years old. For those younger than 18, there is a separate trial and for adults over 65, there are 13 other studies available."

Answered by AI

What is the maximum number of participants being included in this research?

"Affirmative. According to the details listed on clinicaltrials.gov, this scientific trial is actively sourcing participants since its inception on August 9th 2021 and most recent revision on December 9th 2021. With 55 individuals needed from 3 different medical centres, recruitment is currently underway."

Answered by AI

Who meets the criteria for enrolling in this trial?

"This research seeks 55 individuals, between 18-100 years of age, with ileostomy complications. Participants must also have had a new ileostomy formation at their index hospitalization; be willing to complete protocol-mandated tasks and be an inpatient admission at NorthShore University HealthSystem hospital."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Cascade Feasibility Pilot (Ileostomy)

Nirav Shah 2021. "The Cascade Feasibility Pilot (Ileostomy)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05048329.