Smart Imaging: SPY Fluorescence Imaging Systems and Indocyanine Green as a Tool for Developing Intelligent Peri-Operative Imaging

• Sponsor: Stryker Endoscopy (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05006950
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 18.1
• Patients Per Site Per Month: 5.5

Study Details

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 to develop intelligent imaging tools (I-IT), 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.

Condition or Disease	Intervention/Treatment	Phase
Cholecystitis	Device: Stryker1688 Fluorescence imaging system	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: SPY Fluorescence Imaging Systems and Indocyanine Green as a Tool for Developing Intelligent Peri-Operative Imaging
• Actual Study Start Date: Jun 28, 2021
• Anticipated Primary Completion Date: Jun 30, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Outcome Measures

Primary Outcome Measures

1. Outcome 1 [Intra-op visit]

   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

1. Outcome 2 [Intra-op visit]

   To estimate the number of times a surgeon altered the surgical plan due to information identified/revealed by SPY fluorescence imaging

Other Outcome Measures

1. Outcome 3 [Post op follow- up (7-14 days)]

   To estimate the number of post-operative complications (related to gall bladder surgery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Anne Arundel Medical Center	Annapolis	Maryland	United States	21401

Sponsors and Collaborators

• Stryker Endoscopy

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stryker Endoscopy
• ClinicalTrials.gov Identifier: NCT05006950
• Other Study ID Numbers: CRD10283
• First Posted: Aug 16, 2021
• Last Update Posted: Aug 16, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Cholecystitis

Study Results

No Results Posted as of Aug 16, 2021