Clinical trial NCT06700317: Intraoperative Hyperspectral Imaging for Laparoscopic Surgery
Official title: Intraoperative Hyperspectral Imaging for Laparoscopic Surgery (LapHSI): a Multicentre Post-market Clinical Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Colorectal Neoplasms
Colorectal Surgery
Cholecystitis
Cholecystectomy, Laparoscopic
Keywords: hyperspectral imaging
surgery
laparoscopic surgery
colorectal cancer
cholecystitis
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2024-11-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Device safety
timeFrame: From enrollment to end of follow up (30 days)
Secondary outcomes:
measure: Technological performance
timeFrame: Duration of surgery
measure: Utility and usability of tissue oxygenation saturation maps in bowel surgery
timeFrame: Duration of surgery
measure: Utility and usability of tissue oxygenation saturation maps in cholecystectomy
timeFrame: Duration of surgery
measure: Human factors analysis on use of HSS1
timeFrame: Duration of surgery
Other outcomes:
Locations:
Study officials:
References: