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

Sponsor

MiWEndo Solutions S.L. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05988645

Collaborator

(none)

Enrollment

Arm

1.7

Anticipated Duration (Months)

Study Details

Study Description

Brief 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)

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer Colorectal Polyp Colorectal Adenoma Colorectal Adenomatous Polyp Colorectal Adenocarcinoma Colorectal Neoplasms	Device: MiWEndo System	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

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

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Performance and Safety of MiWEndo-assisted Colonoscopy: MiWEndo II (Pivotal Study)

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Sep 22, 2023

Anticipated Study Completion Date :

Sep 22, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MiWEndo + colonoscope All patients will be explored with MiWEndo as an accessory to colonoscopy	Device: MiWEndo System 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

Intervention/Treatment

Experimental: MiWEndo + colonoscope

All patients will be explored with MiWEndo as an accessory to colonoscopy

Device: MiWEndo System

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.

Outcome Measures

Primary Outcome Measures

Number of polyps [During the procedure.]
With MiWEndo assisted colonoscopy, detect at least one polyp before colonoscopy in 10% of patients.
Number of adverse events. [During the procedure and up to 2 weeks after.]
Number of adverse events related with the use of the MiWEndo using the lexicon proposed by the American Society of Gastrointestinal Endoscopy (ASGE) (Cotton PB et al. GIE 2010;71:446-54).
Number of mural injuries. [During the procedure and up to 2 weeks after.]
Mural injuries related with the use of the MiWEndo.

Secondary Outcome Measures

Rate of cecal intubation (yes/no). [During procedure.]
As a relevant parameter for assessing the impact of MiWEndo-assisted colonoscopy on the normal clinical practice, this parameter will be measured as complete colonoscopy (yes/no). In case cecum could not be reached, the distance reached will be measured (either in cm or anatomically, indicating what segment of the colon has been reached).
Length of colon explored (cm). [During the procedure.]
In case cecum could not be reached, the distance will be measured (in cm).
Time reaching cecum and completing (min). Time for reaching the cecum and completing the colonoscopy (in min) will be measured as a relevant parameter for assessing the impact of MiWEndo-assisted colonoscopy in the clinical practice. [During procedure.]
Time for reaching the cecum and completing the colonoscopy (in min) will be measured as a relevant parameter for assessing the impact of MiWEndo-assisted colonoscopy in the clinical practice. Time for reaching the cecum and completing the colonoscopy (in min) will be measured as a relevant parameter for assessing the impact of MiWEndo-assisted colonoscopy in the clinical practice.
Number and size (adenomas and polyps). [During procedure.]
The number and size of all lesions (adenomas and all polyps) detected with MiWEndo-assisted colonoscopy.
True positives (TP), False positives (FP), False negatives (FN). [During procedure.]
The concordance with the lesions detected by the standard colonoscopy (TP, FP, FN).
Patients' comfort. [Immediately after the procedure and 2 weeks after.]
Patients' feedback related to colonoscopy using the Gloucester comfort score that ranges from 1 (no discomfort) to 5 (severe discomfort).
Perception of difficulty. [Immediately after the procedure.]
Perception of difficulty by the endoscopist based on a 5-points Likert scale (very easy to very difficult or very much to very little).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.