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NCT05006950

SPY Fluorescence Imaging Systems and Indocyanine Green to Determine the Percentage of Successful Critical Anatomy Recognition in Laparoscopic Cholecystectomy Surgeries.

Terminated Phase 1 Last updated 19 September 2022
What this trial tests

Phase 1 trial testing Stryker1688 Fluorescence imaging system in Cholecystitis in 50 participants. Terminated before completion.

Timeline
28 June 2021
Primary endpoint
8 February 2022
7 September 2022

Quick facts

Lead sponsorStryker Endoscopy
PhasePhase 1
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposehealth services research
Enrollment50
Start date28 June 2021
Primary completion8 February 2022
Estimated completion7 September 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Stryker Endoscopy

Who can join

18 and older, any sex, with Cholecystitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Cholecystitis

Currently open trials in the same condition.

Other Stryker Endoscopy trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05006950.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing