Colorectal NeoplasmsLapHSINCT06700317
Intraoperative Hyperspectral Imaging for Laparoscopic Surgery
A study testing HSS1 in people with Colorectal Neoplasms and Colorectal Surgery, run by King's College London.
Trial summary
The study aims to evaluate the use of the HyperSnap Surgical System (HSS1) during laparoscopic surgeries, specifically in bowel resections and cholecystectomies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms, Colorectal Surgery, Cholecystitis
- What is being tested?
- HSS1
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2025to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cholelithiasis or cholecystitis with indications for laparoscopic surgery (cholecystectomy)
- Adult patients aged 18 years and over
- Common bile duct diameter < 8mm as assessed using ultrasound
- Patients able to provide written informed consent
- Colorectal cancer requiring elective bowel resection via a laparoscopic approach.
- Adult patients aged 18 years and over
- Patients who are scheduled for elective laparoscopic colon cancer resection
- Patients able to provide written informed consent
Who cannot join
- Cholelithiasis or cholecystitis with indications for laparoscopic surgery (cholecystectomy)
- 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
- Patients who are pregnant
Show all 12Show fewer
- Colorectal cancer requiring elective bowel resection via a laparoscopic approach.
- Patients under 18 years of age
- Patients with a history of previous abdominal surgery and multiply scarred abdomen
- Patients unable to provide written informed consent
- Patients undergoing emergency surgery
- Patients who are pregnant
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Intraoperative Hyperspectral Imaging for Laparoscopic Surgery (LapHSI): a Multicentre Post-market Clinical Study
The study aims to evaluate the use of the HyperSnap Surgical System (HSS1) during laparoscopic surgeries, specifically in bowel resections and cholecystectomies.
Read the detailed description
The study will observe patients undergoing bowel resection and cholecystectomy surgeries to determine if HyperSnap Surgical System (HSS1), as a primary visualisation tool, functions safely and capably as a laparoscopic imager. In addition, we will see if it subjectively improves the identification of critical anatomical structures. In addition, the study will secondarily assess how StO2 information may be included in the surgical workflow and how surgeons may react to this additional information.
- Being tested
- HSS1
- Keywords
- hyperspectral imaging, surgery, laparoscopic surgery, colorectal cancer, cholecystitis
- Medical subject headings
- Colorectal Neoplasms, Cholecystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSS1Device
Surgery performed using HSS1
| Study group | Role | What they receive |
|---|---|---|
| HSS1 | Experimental | Surgery performed using HSS1 Receives: Device: HSS1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to end of follow up (30 days)
Secondary outcomes (4)
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.
Measured: Duration of surgery
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
Measured: Duration of surgery
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.
Measured: Duration of surgery
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.
Measured: Duration of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start1 Feb 2025 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06700317
- Sponsor's protocol ID
- 321001
- Acronym
- LapHSI
- Status last verified
- Nov 2024
- First submitted
- 20 Nov 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Hyperspectral Imaging for Laparoscopic Surgery (LapHSI): a Multicentre Post-market Clinical Study
- ClinicalTrials.gov ID
- NCT06700317
- Acronym / sponsor ID
- LapHSI / 321001
- Keywords
- hyperspectral imaging, surgery, laparoscopic surgery, colorectal cancer, cholecystitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 21 Nov 2024 (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.
The study aims to evaluate the use of the HyperSnap Surgical System (HSS1) during laparoscopic surgeries, specifically in bowel resections and cholecystectomies.
Detailed description
The study will observe patients undergoing bowel resection and cholecystectomy surgeries to determine if HyperSnap Surgical System (HSS1), as a primary visualisation tool, functions safely and capably as a laparoscopic imager. In addition, we will see if it subjectively improves the identification of critical anatomical structures. In addition, the study will secondarily assess how StO2 information may be included in the surgical workflow and how surgeons may react to this additional information.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HSS1 | Experimental | Device: HSS1Surgery performed using HSS1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Cholelithiasis or cholecystitis with indications for laparoscopic surgery (cholecystectomy)
- Adult patients aged 18 years and over
- Common bile duct diameter < 8mm as assessed using ultrasound
- Patients able to provide written informed consent
- Colorectal cancer requiring elective bowel resection via a laparoscopic approach.
Key exclusion criteria (12 listed)
- Cholelithiasis or cholecystitis with indications for laparoscopic surgery (cholecystectomy)
- 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
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 |
|---|---|---|
| HSS1Surgery performed using HSS1 | Device | HSS1 |
Primary outcome
Device safety
Time frame: From enrollment to end of follow up (30 days)
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.
4 secondary outcomes
Technological performance
Time frame: Duration of surgery
Utility and usability of tissue oxygenation saturation maps in bowel surgery
Time frame: Duration of surgery
Utility and usability of tissue oxygenation saturation maps in cholecystectomy
Time frame: Duration of surgery
Human factors analysis on use of HSS1
Time frame: Duration of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing HSS1 in people with Colorectal Neoplasms and Colorectal Surgery, run by King's College London.
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 8 inclusion and 12 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: opening soon, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Shapey, PhD FHEA FRCS (+44 20 7836 5454, jonathan.shapey@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device safety (time frame: From enrollment to end of follow up (30 days)). 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 21 Nov 2024.