ICG dye for Fistula

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University Health Network, Toronto, CanadaFistulaICG dye - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether using ICG to measure blood flow during surgery can help reduce the incidence of fistulas.

Eligible Conditions
  • Surgery Site Fistula

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

2 Primary · 3 Secondary · Reporting Duration: Collected at times week 1, 3 months, 6 months, and 12 months

Month 12
Speech and Swallowing Questionnaire
Collected at time of surgery
ICG Perfusion
Month 12
Disease Status
Laryngeal Rehabilitation
Week 1
Surgical Complications

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
ICG
1
MSC-AFP
1
Mesenchymal stem cells

Trial Design

2 Treatment Groups

Control
1 of 2
ICG
1 of 2

Active Control

Experimental Treatment

70 Total Participants · 2 Treatment Groups

Primary Treatment: ICG dye · No Placebo Group · Phase 2

ICG
Other
Experimental Group · 1 Intervention: ICG dye · Intervention Types: Other
ControlNoIntervention Group · 1 Intervention: Control · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: collected at times week 1, 3 months, 6 months, and 12 months

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,387 Previous Clinical Trials
472,004 Total Patients Enrolled
2 Trials studying Fistula
262 Patients Enrolled for Fistula
Sunnybrook Health Sciences CentreOTHER
607 Previous Clinical Trials
1,468,105 Total Patients Enrolled
2 Trials studying Fistula
67 Patients Enrolled for Fistula

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The area in your throat being studied should be visible using ICG imaging.
References

Frequently Asked Questions

Is enrollment for this research endeavor currently ongoing?

"As indicated on clinicaltrials.gov, recruitment for this study is ongoing and has been since 11/11/2021 (last edited 5/30/2022)." - Anonymous Online Contributor

Unverified Answer

How many individuals have committed to participating in this experiment?

"Affirmative, information available on clinicaltrials.gov shows that this medical trial is currently seeking participants; it was initially posted in November of 2021 and last updated May 30th 2022. Seventy patients are needed from a single location." - Anonymous Online Contributor

Unverified Answer

What adverse effects could be caused by the introduction of ICG dye to a patient's system?

"The safety of ICG dye was rated a 2, as there is some evidence that it can function safely in clinical trials but no data demonstrating its efficacy." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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