Intraoperative Hyperspectral Imaging for Laparoscopic Surgery (LapHSI)

November 20, 2024 updated by: King's College London

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

A) 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

B) 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

Exclusion Criteria:

A) 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

B) 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HSS1
Surgery performed using HSS1
Device: HSS1
Surgery performed using HSS1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to end of follow up (30 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technological performance
Time Frame: Duration of surgery
To determine any undesirable side effects in technological performance and assess whether these constitute risks when weighed against the intended performance of the device.
Duration of surgery
Utility and usability of tissue oxygenation saturation maps in bowel surgery
Time Frame: Duration of 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
Duration of surgery
Utility and usability of tissue oxygenation saturation maps in cholecystectomy
Time Frame: Duration of surgery
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.
Duration of surgery
Human factors analysis on use of HSS1
Time Frame: Duration of surgery
To perform a human factor analysis of the use of the UKCA marked medical device (HSS1) in relation to surgical workflow and surgeon performance.
Duration of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

November 20, 2024

First Submitted That Met QC Criteria

November 20, 2024

First Posted (Estimated)

November 21, 2024

Study Record Updates

Last Update Posted (Estimated)

November 21, 2024

Last Update Submitted That Met QC Criteria

November 20, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 321001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Colorectal Neoplasms

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Switzerland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe