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NCT Number: NCT06700317

Intraoperative Hyperspectral Imaging for Laparoscopic Surgery

The study aims to evaluate the use of the HyperSnap Surgical System (HSS1) during laparoscopic surgeries, specifically in bowel resections and cholecystectomies.

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Key information

Conditions

Colorectal Neoplasms Biliary Tract Diseases Cholecystectomy, Laparoscopic Cholecystitis Colonic Diseases Colorectal Surgery Digestive System Diseases Digestive System Neoplasms Gallbladder Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HSS1

Device

Surgery performed using HSS1

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jonathan Shapey, PhD FHEA FRCS

CONTACT

[email protected]

+44 20 7836 5454

Sponsors and collaborators

Lead sponsor

King's College London

Other

Registry information

Official study title

Intraoperative Hyperspectral Imaging for Laparoscopic Surgery (LapHSI): a Multicentre Post-market Clinical Study

Acronym: LapHSI

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 21, 2024
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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