Performance and Safety of MiWEndo-assisted Colonoscopy (MiWEndo II)

Trial Title: Performance and Safety of MiWEndo-assisted Colonoscopy (MiWEndo II)

NCT ID: NCT05988645

Condition: Colorectal Cancer
Colorectal Polyp
Colorectal Adenoma
Colorectal Adenomatous Polyp
Colorectal Adenocarcinoma
Colorectal Neoplasms

Conditions: Official terms:
Colorectal Neoplasms
Adenoma
Adenomatous Polyps
Polyps

Conditions: Keywords:
microwave imaging
colonoscopy
early diagnosis
colorectal cancer screening

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Single Group Assignment Traditional safety and performance study, following a single-center prospective and noncomparative.

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: MiWEndo System
Description: All colonoscopies will be performed with high-definition technology. The MiWEndo System will be fitted to the tip of the endoscope before colonoscopy is started and connected to the microwave processor unit. Endoscopies will be performed by experienced endoscopists who will be previously trained on the use of the MiWEndo System. The MiWEndo Analyzer will be managed by the assistant. At the beginning of the extubation, the MiWEndo System will be turned on and the endoscopist will put music headphones on (blind to the results of MiWEndo). In case one of them identifies a polyp, the exploration will be stopped and check if it has been detected by the alternative method as well. All the polyps will be resected and sent to the Pathological Department for histological analysis following the usual clinical practice. A stopwatch will be used to measure both total procedure time and withdrawal time.
Arm group label: MiWEndo + colonoscope

Summary: The study involves the planned use of a new microwave-based device during colonoscopy procedures in 50 patients to assess the performance and safety of its use for detection of colorectal polyps and lack of normal clinical practice modification. The device is a final design version, which has been previously tested in several preclinical studies (including phantom studies, an ex vivo study with human tissues, and an in vivo study with porcine model) and in a pilot study in humans (NCT05477836)

Detailed description: This study is designed as a single-center prospective, non-comparative study in 50 patients, whereby data will be subject to an analytical description, rather than to a statistical treatment (refer to Statistical design and analysis). In this study the principal aims are to assess the performance and safety of the device for the detection of colorectal polyps when used as an accessory to colonoscopy. Relevant claims to verify in this study are that the device will detect in first instance polyps not detected initially with the endoscopic image and can be used without ADEs, without any change in the current clinical practice, as well as without any major difficulty by the endoscopist, neither in the preparation nor in the use of the device during exploration. In addition, in the first phase of the study (n=15 patients), the study aims to gather real clinical data with the use of the device to optimise the processing software that will be key to demonstrate MiWEndo's performance on the second part of the study (n=35 patients). Consequently, principal and secondary objectives of this investigation, are: Principal objectives: - To assess the performance of MiWEndo-assisted colonoscopy in the detection of colorectal polyps. - To assess the safety of MiWEndo-assisted colonoscopy. Secondary objectives: - To assess the feasibility of performing a complete colonoscopy using the MiWEndo device. - To assess the perception of difficulty by the endoscopist when the device is used. - To assess the operator learning curve with MiWEndo-assisted colonoscopy to guide future recommendations for training. - To provide exploratory analysis of differences in MiWEndo-assisted colonoscopy in different groups of patients to guide future RCT. - To assess the patient's comfort.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Patients with previously resected polyps. - Patients with hereditary polyposis syndromes. - Patients with Lynch Syndrome. - Patients with familial cancer. These criteria will ensure the probability of finding polyps during the explorations. All the patients will give written informed consent. Exclusion Criteria: - Patients at a high risk of having major complications as perforation or hemorrhage or in whom the possibility of performing a complete colonoscopy is reduced, including: patients with known colonic strictures, total or partial colectomy, acute diverticulitis, abdominal surgery, inflammatory bowel disease, suspected or proven lower gastrointestinal bleeding, non-correctable coagulopathy or anticoagulant/clopidogrel therapy during procedure, inadequate bowel cleansing or previous incomplete colonoscopy. - ASA-IV patients. - Urgent colonoscopy.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Hospital Clinic

Address:
City: Barcelona
Country: Spain

Status: Recruiting

Contact:
Last name: Glòria Fernández

Phone: 0034626710677
Email: mgfernan@clinic.cat

Start date: August 1, 2023

Completion date: December 29, 2024

Lead sponsor:
Agency: MiWEndo Solutions S.L.
Agency class: Industry

Source: MiWEndo Solutions S.L.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05988645