Intraoperative Hyperspectral Imaging for Laparoscopic Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKing's College London
About this trial
The study aims to evaluate the use of the HyperSnap Surgical System (HSS1) during laparoscopic surgeries, specifically in bowel resections and cholecystectomies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients aged 18 years and over
Common bile duct diameter < 8mm as assessed using ultrasound
Patients able to provide written informed consent
Adult patients aged 18 years and over
Disqualifiers
Patients under 18 years of age
Patients with a history of previous abdominal surgery and multiply scarred abdomen
Common bile duct diameter ≥ 8mm as assessed using ultrasound
Patients unable to provide written informed consent
Trial design
Design model
Single group
Treatments tested in this trial
HSS1
DeviceSurgery performed using HSS1
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: HSS1Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Device safety
To demonstrate that under normal conditions of use, the performance characteristics of the device are those intended, enabling laparoscopic abdominal surgery to be safely performed using the UKCA-marked medical device (HSS1) as the primary surgical visualisation system.
Time frame
From enrollment to end of follow up (30 days)Secondary outcomes
1
Technological performance
To determine any undesirable side effects in technological performance and assess whether these constitute risks when weighed against the intended performance of the device.
Time frame
Duration of surgery2
Utility and usability of tissue oxygenation saturation maps in bowel surgery
To assess the utility and usability of tissue oxygen saturation maps in bowel resection surgery for delineation of intestinal angiosomes and how the additional StO2 biomarker influenced clinical decision making
Time frame
Duration of surgery3
Utility and usability of tissue oxygenation saturation maps in cholecystectomy
To perform retrospective analysis of the utility and usability of tissue oxygen saturation maps in cholecystectomy (not shown during procedure) for delineation of relevant anatomical structures within the surgical field.
Time frame
Duration of surgery4
Human factors analysis on use of HSS1
To perform a human factor analysis of the use of the UKCA marked medical device (HSS1) in relation to surgical workflow and surgeon performance.
Time frame
Duration of surgeryLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: