Neoplasms

Digestive System Diseases

All Conditions

Symptoms and General Pathology

Colorectal Neoplasms

Adenocarcinoma

Adenoma

Polyps

Adenomatous Polyps

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pathological Conditions, Anatomical

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

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.

MiWEndo System

Glòria Fernández

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)

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.

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

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

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

With MiWEndo assisted colonoscopy, detect at least one polyp before colonoscopy in 10% of patients.

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).

Mural injuries related with the use of the MiWEndo.

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).

In case cecum could not be reached, the distance will be measured (in cm).

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.

The number and size of all lesions (adenomas and all polyps) detected with MiWEndo-assisted colonoscopy.

The concordance with the lesions detected by the standard colonoscopy (TP, FP, FN).

Patients' feedback related to colonoscopy using the Gloucester comfort score that ranges from 1 (no discomfort) to 5 (severe discomfort).

Perception of difficulty by the endoscopist based on a 5-points Likert scale (very easy to very difficult or very much to very little).

MiWEndo Solutions S.L.

Pharmaceutical Solutions

All Drugs and Chemicals

All colonoscopies will be performed with high-definition technology. The MiWEndo System (MiWEndo Solutions, Barcelona) 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.

At the beginning of the extubation, the MiWEndo System will be turned on. During extubation, each segment will be carefully examined with both white light and 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.

MiWEndo-assisted colonoscopy

The study involves the planned use of a new microwave-based device during colonoscopy procedures in a small group of patients to assess the preliminary safety of its use 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 animal model (pig).

This study is designed as a single-center prospective, non-comparative, first in human pilot safety and feasibility study with few 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 aim is to assess the clinical safety of the device and the feasibility of its use in assisted colonoscopy. Relevant claims to verify in this study are that the device 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, 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 a subsequent clinical investigation (pivotal study).

Consequently, principal and secondary objectives of this investigation, are:

* Principal objectives:

  * To assess the feasibility of performing a complete colonoscopy using the MiWEndo System.
  * To assess the safety of MiWEndo colonoscopy.
* Secondary objectives:

  * To assess the perception of difficulty by the endoscopist when the device is used.
  * To assess the patient's comfort.
  * To collect data on polyp detection performance to guide possible further improvements of the software before starting the pivotal study.

Traditional feasibility study, following a single-center prospective, non-comparative, with few patients design.

Feasibility and Safety of MiWEndo-assisted Colonoscopy

Feasibility and Safety of MiWEndo-assisted Colonoscopy:Pilot Study

To assess the safety of MiWEndo colonoscopy using the lexicon proposed by the American Society of Gastrointestinal Endoscopy (ASGE).

To assess the safety of MiWEndo colonoscopy according to the Sydney classification for deep mural injuries (DMI)

To assess the feasibility of performing a complete colonoscopy using the MiWEndo System. This parameter will be measured as complete colonoscopy (yes/no).

Subjective assessment from patient following the Gloucester 5-Likert scale, where 1 is no discomfort and 5 is extreme discomfort.

Difficulty by the endoscopist subjectively assessed based on a 5-points Likert scale, where 0 is not difficult and 4 is very difficult.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Performance and Safety of MiWEndo-assisted Colonoscopy (MiWEndo II)	NCT05988645	Colorectal Canc... Colorectal Poly... Colorectal Aden... Colorectal Aden... Colorectal Aden... Colorectal Neop...	MiWEndo System	18 Years -	MiWEndo Solutions S.L.
Feasibility and Safety of MiWEndo-assisted Colonoscopy	NCT05477836	Colorectal Canc... Colorectal Poly... Colorectal Aden... Colorectal Neop... Colorectal Aden... Colorectal Aden...	MiWEndo-assiste...	50 Years -	MiWEndo Solutions S.L.
Feasibility and Safety of MiWEndo-assisted Colonoscopy	NCT05477836	Colorectal Canc... Colorectal Poly... Colorectal Aden... Colorectal Neop... Colorectal Aden... Colorectal Aden...	MiWEndo-assiste...	50 Years -	MiWEndo Solutions S.L.

Spots Global Cancer Trial Database for microwave imaging