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Imaging Device

Cellvizio 100 Series System with Confocal Miniprobes for Ventricular Septal Defects (OPTIMA Trial)

Phase 2
Waitlist Available
Led By Aditya K Kaza, MD
Research Sponsored by Aditya Kaza
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year post-surgery
Awards & highlights

OPTIMA Trial Summary

This trial will test whether FCM can help avoid conduction abnormalities during surgery to repair common congenital heart defects.

Eligible Conditions
  • Ventricular Septal Defect
  • Tetralogy of Fallot
  • Complete Atrioventricular Canal

OPTIMA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year post-surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post-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
Rate of new conduction disorders
Secondary outcome measures
Adverse events
Change in PR interval
Change in QRS interval
+7 more

Side effects data

From 2019 Phase 1 trial • 6 Patients • NCT03189134
100%
Constipation
100%
Pain
67%
Atelectasis
50%
Anemia
33%
Pleural effusion
33%
Pneumothorax
33%
Edema
33%
Nausea
33%
Vomiting
17%
Hypertension
17%
Insomnia
17%
Agitation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Imaging Arm

OPTIMA Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Imaging cohortExperimental Treatment2 Interventions
Up to 5mL of 1:1000 dilute fluorescite will be applied to cardiac tissue prior to imaging with Cellvizio 100 Series System with Confocal Miniprobes. The system will be used to assist the investigator with the operative course.
Group II: Non-imaging cohortActive Control1 Intervention
There will be no intervention for the non-imaging group. Subjects will receive standard of care for cardiac surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluorescite
2018
Completed Phase 1
~10
Cellvizio 100 Series System with Confocal Miniprobes
2018
Completed Phase 1
~10

Find a Location

Who is running the clinical trial?

Aditya KazaLead Sponsor
1 Previous Clinical Trials
6 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,834 Previous Clinical Trials
47,310,565 Total Patients Enrolled
Aditya K Kaza, MDPrincipal InvestigatorBoston Children's Hospital

Frequently Asked Questions

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

How many participants are being accepted to this clinical trial?

"Unfortunately, this medical research is not presently seeking out new participants. Initially posted on December 20th 2019 and last updated on December 7th 2022, if you are looking to explore other studies there are currently 8 trials recruiting patients with the Cellvizio 100 Series System with Confocal Miniprobes as well as 20 clinical trials actively admitting those with ventricular septal defects (vsd)."

Answered by AI

Is the subject pool of this medical trial inclusive of those who have attained 80 years or more?

"The participants of this trial must be between 30 days and 18 years old. There are 21 studies for minors and 17 trials specifically targeting seniors aged 65 or above."

Answered by AI

To what extent is Cellvizio 100 Series System with Confocal Miniprobes safe for human use?

"Cellvizio 100 Series System with Confocal Miniprobes has been assigned a rating of 2 on our safety scale since the device is currently in Phase 2 trials and there are promising signs concerning its security, but no evidence attesting to its efficacy."

Answered by AI

Could you elaborate on the research conducted with Cellvizio 100 Series System and Confocal Miniprobes?

"As of now, there is one Phase 3 study being conducted with the Cellvizio 100 Series System and Confocal Miniprobes. Centred in Aurora, Colorado, this trial has a total of 223 research sites operating within it."

Answered by AI

What ailments is the Cellvizio 100 Series System with Confocal Miniprobes commonly employed to alleviate?

"The Cellvizio 100 Series System with Confocal Miniprobes can be deployed to treat peritoneal dialysis therapy, measure lymphocyte count, and diagnose genus pneumocystis."

Answered by AI

Are recruitment efforts for this research currently underway?

"Unfortunately, this particular clinical trial is not presently seeking any additional participants. The original post was published on December 20th 2019 and the last update occurred on December 7th 2022. For individuals looking for alternative trials, there are currently twenty studies recruiting patients with ventricular septal defects (VSD) and eight investigations actively enrolling subjects using the Cellvizio 100 Series System with Confocal Miniprobes."

Answered by AI

What criteria are necessary to qualify for participation in this clinical trial?

"Eligibility requirements for this trial include patients between 30 days and 18 years old that are living with a ventricular septal defect (VSD). Approximately 70 people will be selected."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Optical Tissue Identification for Myocardial Architecture
Aditya Kaza 2019. "Optical Tissue Identification for Myocardial Architecture". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04017975.
~13 spots leftby Apr 2025
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