Back to resultsSPY Fluorescence Imaging Systems and Indocyanine Green to Determine the Percentage of Successful Critical Anatomy Recognition in Laparoscopic Cholecystectomy Surgeries.
Primary Purpose
Cholecystitis
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Stryker1688 Fluorescence imaging system
Sponsored by
About this trial
This is an interventional health services research trial for Cholecystitis
Eligibility Criteria
Inclusion Criteria:
- Subject is 18 years of age or older
- Subject is scheduled to undergo laparoscopic cholecystectomy, elective or emergent
- Subject provides informed consent and signs an approved informed consent document for the study
- Subject is willing to comply with the protocol and study visit schedule
Exclusion Criteria:
- Subject is pregnant or lactating
- Subject has a known allergy or history of adverse reaction to ICG, iodine or iodine dyes
- Subject has known history of cholangitis, pancreatitis, prior bile duct injury, coagulopathy or known pre-existing liver disease
- Subjects who, in the Investigator's opinion, have any medical condition that may make the subject a poor candidate for the investigation, interferes with the interpretation of study results, or integrity of the study
Sites / Locations
- Anne Arundel Medical Center
Outcomes
Primary Outcome Measures
Outcome 1
To determine the percentage of successful critical anatomy recognition using intra-operative SPY fluorescence imaging and ICG in subjects undergoing laparoscopic cholecystectomy
Secondary Outcome Measures
Outcome 2
To estimate the number of times a surgeon altered the surgical plan due to information identified/revealed by SPY fluorescence imaging
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05006950
Brief Title
SPY Fluorescence Imaging Systems and Indocyanine Green to Determine the Percentage of Successful Critical Anatomy Recognition in Laparoscopic Cholecystectomy Surgeries.
Official Title
SPY Fluorescence Imaging Systems and Indocyanine Green to Determine the Percentage of Successful Critical Anatomy Recognition in Laparoscopic Cholecystectomy Surgeries.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Terminated
Why Stopped
Business/strategic reasons and low accrual rate
Study Start Date
June 28, 2021 (Actual)
Primary Completion Date
February 8, 2022 (Actual)
Study Completion Date
September 7, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stryker Endoscopy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a prospective single arm, single center study estimating percentage of successful critical anatomy recognition in laparoscopic cholecystectomy surgeries using SPY fluorescence imaging and ICG, with each surgery also providing a white light 360 degree images.
The primary objective is to determine the percentage of successful critical anatomy recognition using intra-operative SPY fluorescence imaging and ICG: and to describe complications associated with intra-operative decision making in patients undergoing laparoscopic cholecystectomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystitis
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Stryker1688 Fluorescence imaging system
Intervention Description
The purpose of this study is to use SPY fluorescence imaging systems and indocyanine green (ICG) as a tool to determine the percentage of successful critical anatomy recognition and to describe complications associated with intra-operative decision making in patients undergoing laparoscopic cholecystectomy.
Primary Outcome Measure Information:
Title
Outcome 1
Description
To determine the percentage of successful critical anatomy recognition using intra-operative SPY fluorescence imaging and ICG in subjects undergoing laparoscopic cholecystectomy
Time Frame
Intra-op visit
Secondary Outcome Measure Information:
Title
Outcome 2
Description
To estimate the number of times a surgeon altered the surgical plan due to information identified/revealed by SPY fluorescence imaging
Time Frame
Intra-op visit
Other Pre-specified Outcome Measures:
Title
Outcome 3
Description
To estimate the number of post-operative complications (related to gall bladder surgery
Time Frame
Post op follow- up (7-14 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subject is 18 years of age or older
Subject is scheduled to undergo laparoscopic cholecystectomy, elective or emergent
Subject provides informed consent and signs an approved informed consent document for the study
Subject is willing to comply with the protocol and study visit schedule
Exclusion Criteria:
Subject is pregnant or lactating
Subject has a known allergy or history of adverse reaction to ICG, iodine or iodine dyes
Subject has known history of cholangitis, pancreatitis, prior bile duct injury, coagulopathy or known pre-existing liver disease
Subjects who, in the Investigator's opinion, have any medical condition that may make the subject a poor candidate for the investigation, interferes with the interpretation of study results, or integrity of the study
Facility Information:
Facility Name
Anne Arundel Medical Center
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
SPY Fluorescence Imaging Systems and Indocyanine Green to Determine the Percentage of Successful Critical Anatomy Recognition in Laparoscopic Cholecystectomy Surgeries.
We'll reach out to this number within 24 hrs