Intraoperative Hyperspectral Imaging for Laparoscopic Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HSS1.
- Who it may be relevant to
- Registry conditions: Colorectal Neoplasms, Colorectal Surgery, Cholecystitis, Cholecystectomy, Laparoscopic. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Intraoperative Hyperspectral Imaging for Laparoscopic Surgery (LapHSI): a Multicentre Post-market Clinical Study
Overview
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.
Interventions
- Device HSS1
Surgery performed using HSS1
Primary outcome measures
- Device safety [Time frame: From enrollment to end of follow up (30 days)]
Secondary outcome measures (4)
- 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06700317 · 321001