Intraoperative Hyperspectral Imaging for Laparoscopic Surgery

NCT ID: NCT06700317

Last Updated: 2024-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2025-08-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Colorectal Neoplasms Colorectal Surgery Cholecystitis Cholecystectomy, Laparoscopic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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HSS1

Surgery performed using HSS1

Group Type EXPERIMENTAL

HSS1

Intervention Type DEVICE

Surgery performed using HSS1

Interventions

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HSS1

Surgery performed using HSS1

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King's College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Jonathan Shapey, PhD FHEA FRCS

Role: CONTACT

+44 20 7836 5454

Other Identifiers

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321001

Identifier Type: -

Identifier Source: org_study_id

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