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Intraoperative Hyperspectral Imaging for Laparoscopic Surgery (LapHSI)

K

King's College London

Status

Begins enrollment in 1 month

Conditions

Cholecystitis
Cholecystectomy, Laparoscopic
Colorectal Surgery
Colorectal Neoplasms

Treatments

Device: HSS1

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

HSS1
Experimental group
Description:
Surgery performed using HSS1
Treatment:
Device: HSS1

Trial contacts and locations

0

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Central trial contact

Jonathan Shapey, PhD FHEA FRCS

Data sourced from clinicaltrials.gov

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