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Continuous Glucose Monitoring for Free Tissue Flap Ischemia

Q: Are new participants currently being accepted into this medical experiment?

<p>Details stored on clinicaltrials.gov reveal that this research project is not accepting new participants. Initially posted in November 2015 and most recently amended, the trial was closed without any additional recruits being sought out; however, there are two other studies which have open recruitment periods right now.</p>

Phase < 1

Waitlist Available

Led By Ronen Avram, MD

Research Sponsored by Hamilton Health Sciences Corporation

Eligibility Criteria Checklist

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

Must have

Patients who are undergoing unilateral or bilateral breast reconstruction with free flap including DIEP flaps at Hamilton Health Sciences, starting from the date of ethics approval.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 6 days after surgery

Awards & highlights

Study Summary

This trial will test whether a Continuous Glucose Monitor (CGM) can be used to detect early postoperative flap ischemia, which could improve flap salvage and survival rates.

Who is the study for?

This trial is for patients at Hamilton Health Sciences undergoing breast reconstruction with free flap surgery, specifically DIEP flaps. It's not for those on immunosuppressants, using expanders/implants in reconstruction, with active infections or diabetes.Check my eligibility

What is being tested?

The study tests the use of a Continuous Glucose Monitor (CGM) to detect early postoperative tissue ischemia in free flap surgeries. The goal is to see if CGM can reliably measure interstitial glucose levels as an indicator of adequate blood flow to the tissue.See study design

What are the potential side effects?

Since this trial involves monitoring technology rather than medication, traditional side effects are minimal. However, there may be skin irritation or discomfort where the CGM device attaches to the patient.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am having breast reconstruction with my own tissue at Hamilton Health Sciences.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 6 days after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 6 days after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 6 days after surgery for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Temporal correlation between interstitial glucose measurements and flap ischemia

Secondary outcome measures

Incidence of major adverse effects related to the device

Incidence of minor side effects related to device

Incidences of technical issues related to the device

Trial Design

1Treatment groups

Experimental Treatment

Group I: Continuous Glucose MonitorExperimental Treatment1 Intervention

Application of CGM for 6 days following free flap reconstruction in conjunction with clinical monitoring

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Continuous Glucose Monitor

2021

Completed Early Phase 1

~860

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hamilton Health Sciences CorporationLead Sponsor

368 Previous Clinical Trials

300,963 Total Patients Enrolled

Thoma, AchilleasINDIV

Jiayi HuUNKNOWN

Media Library

Continuous Glucose Monitor Clinical Trial Eligibility Overview. Trial Name: NCT02604069 — Phase < 1

Free Tissue Flaps Research Study Groups: Continuous Glucose Monitor

Free Tissue Flaps Clinical Trial 2023: Continuous Glucose Monitor Highlights & Side Effects. Trial Name: NCT02604069 — Phase < 1

Continuous Glucose Monitor 2023 Treatment Timeline for Medical Study. Trial Name: NCT02604069 — Phase < 1

Frequently Asked Questions

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

Are new participants currently being accepted into this medical experiment?

"Details stored on clinicaltrials.gov reveal that this research project is not accepting new participants. Initially posted in November 2015 and most recently amended, the trial was closed without any additional recruits being sought out; however, there are two other studies which have open recruitment periods right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Detection of Flap Ischemia Using Interstitial Glucose Monitor

Ronen Avram 2015. "Detection of Flap Ischemia Using Interstitial Glucose Monitor". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02604069.