CholecystitisPhase 1NCT05006950
SPY Fluorescence Imaging Systems and Indocyanine Green to Determine the Percentage of Successful Critical Anatomy Recognition in Laparoscopic Cholecystectomy Surgeries.
A Phase 1 study testing Stryker1688 Fluorescence imaging system in people with Cholecystitis, run by Stryker Endoscopy at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cholecystitis
- What is being tested?
- Stryker1688 Fluorescence imaging system
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2021to 7 Sep 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Anne Arundel Medical Center
Annapolis, Maryland, 21401
About this study
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.
- Conditions
- Cholecystitis
- Being tested
- Stryker1688 Fluorescence imaging system
- Medical subject headings
- Cholecystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stryker1688 Fluorescence imaging systemDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome 1
To determine the percentage of successful critical anatomy recognition using intra-operative SPY fluorescence imaging and ICG in subjects undergoing laparoscopic cholecystectomy
Measured: Intra-op visit
Secondary outcomes (1)
Outcome 2
To estimate the number of times a surgeon altered the surgical plan due to information identified/revealed by SPY fluorescence imaging
Measured: Intra-op visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start28 Jun 2021
- Primary completion8 Feb 2022
- Study completion7 Sep 2022
Why it stopped: Business/strategic reasons and low accrual rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholecystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Endoscopy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05006950
- Sponsor's protocol ID
- CRD10283
- Status last verified
- Sep 2022
- First submitted
- 9 Aug 2021
- Last updated
- 19 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPY Fluorescence Imaging Systems and Indocyanine Green to Determine the Percentage of Successful Critical Anatomy Recognition in Laparoscopic Cholecystectomy Surgeries.
- ClinicalTrials.gov ID
- NCT05006950
- Acronym / sponsor ID
- CRD10283
- Conditions
- Cholecystitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business/strategic reasons and low accrual rate
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Stryker EndoscopyIndustry (pharma, biotech, devices)
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 8 Feb 2022 (actual)
- Study completion
- 7 Sep 2022 (actual)
- First posted
- 16 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stryker1688 Fluorescence imaging systemThe 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. | Device | – |
Primary outcome
Outcome 1
Time frame: 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
1 secondary outcome
Outcome 2
Time frame: Intra-op visit
Results and safety
The study was stopped early (reason given: Business/strategic reasons and low accrual rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
- Individual participant dataSharing planned: No
Related trials for Cholecystitis
Recruiting
Ultrasound-Guided Rectus Sheath Block Versus Local Infiltration
Cholelithiases, Cholecystitis
Recruiting
STALL vs Sole Local Wound Infiltration in Laparoscopic Cholecystectomy
Cholelithiasis, Cholecystitis
Not yet recruitingObservational study
SnapChole: An International, Time-Bound Prospective Platform Study of Management Strategies and Outcomes in Acute Calculous Cholecystitis
Cholecystitis, Acute
Not yet recruiting
Percutaneous Drainage Versus EUS-guided Gallbladder Drainage in Poor Surgical Patients With Cholecystitis
Cholecystitis, Acute
Not yet recruiting
Supraglottic Oxygenation Via Oral Transtracheal Catheter for Reducing the Incidence of Hypoxemia During ERCP Under Sedation
Choledocholithiasis With Cholecystitis With Obstruction, Obstructive Jaundice
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Stryker1688 Fluorescence imaging system in people with Cholecystitis, run by Stryker Endoscopy at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Business/strategic reasons and low accrual rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outcome 1 (time frame: Intra-op visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2022.