Colorectal CancerNCT05988645
Performance and Safety of MiWEndo-assisted Colonoscopy (MiWEndo II)
A study testing MiWEndo System in people with Colorectal Cancer and Colorectal Polyp, run by MiWEndo Solutions S.L. at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Colorectal Polyp, Colorectal Adenoma
- What is being tested?
- MiWEndo System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 1 Aug 2023to 29 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 18-year-old referred for a screening or surveillance colonoscopy because of a high-risk condition of developing colorectal cancer or having colorectal polyps as fecal occult blood test (FOBT) positive, previously resected polyps under surveillance, hereditary polyposis syndromes, Lynch Syndrome or familial cancer.
- These criteria will ensure the probability of finding polyps during the explorations.
- All the patients will give written informed consent.
Who cannot join
- Patients at a high risk of having major complications as perforation or hemorrhage, suspected or proven lower gastrointestinal bleeding, non-correctable coagulopathy or anticoagulant/clopidogrel therapy during procedure, inadequate bowel cleansing.
- ASA-IV patients.
- Urgent colonoscopy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinic
Barcelona
Glòria Fernández, 0034626710677, mgfernan@clinic.cat
About this study
Official title: Performance and Safety of MiWEndo-assisted Colonoscopy: MiWEndo II (Pivotal Study)
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)
Read the 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 perception of difficulty by the endoscopist when the device is used.
- 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.
- Conditions
- Colorectal Cancer, Colorectal Polyp, Colorectal Adenoma, Colorectal Adenomatous Polyp, Colorectal Adenocarcinoma, Colorectal Neoplasms
- Being tested
- MiWEndo System
- Keywords
- microwave imaging, colonoscopy, early diagnosis, colorectal cancer screening
- Medical subject headings
- Colorectal Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiWEndo SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| MiWEndo + colonoscope | Experimental | All patients will be explored with MiWEndo as an accessory to colonoscopy Receives: Device: MiWEndo System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of polyps
With MiWEndo assisted colonoscopy, detect at least one polyp before colonoscopy in 10% of patients.
Measured: During the procedure.
Number of adverse events.
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).
Measured: During the procedure and up to 2 weeks after.
Number of mural injuries.
Mural injuries related with the use of the MiWEndo.
Measured: During the procedure and up to 2 weeks after.
Secondary outcomes (4)
Number and size (adenomas and polyps).
The number and size of all lesions (adenomas and all polyps) detected with MiWEndo-assisted colonoscopy.
Measured: During procedure.
True positives (TP), False positives (FP), False negatives (FN).
The concordance with the lesions detected by the standard colonoscopy (TP, FP, FN).
Measured: During procedure.
Patients' comfort.
Patients' feedback related to colonoscopy using the Gloucester comfort score that ranges from 1 (no discomfort) to 5 (severe discomfort).
Measured: Immediately after the procedure and 2 weeks after.
Perception of difficulty.
Perception of difficulty by the endoscopist based on a 5-points Likert scale (very easy to very difficult or very much to very little).
Measured: Immediately after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Aug 2023
- Primary completion29 Nov 2026 (estimated)
- Study completion29 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment Traditional safety and performance study, following a single-center prospective and noncomparative.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MiWEndo Solutions S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05988645
- Sponsor's protocol ID
- MW II-CIP
- Status last verified
- Oct 2026
- First submitted
- 1 Aug 2023
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance and Safety of MiWEndo-assisted Colonoscopy: MiWEndo II (Pivotal Study)
- ClinicalTrials.gov ID
- NCT05988645
- Acronym / sponsor ID
- MW II-CIP
- Conditions
- Colorectal Cancer, Colorectal Polyp, Colorectal Adenoma, Colorectal Adenomatous Polyp, Colorectal Adenocarcinoma, Colorectal Neoplasms
- Keywords
- microwave imaging, colonoscopy, early diagnosis, colorectal cancer screening
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- MiWEndo Solutions S.L.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 29 Nov 2026 (estimated)
- Study completion
- 29 Nov 2026 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 perception of difficulty by the endoscopist when the device is used.
- 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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment Traditional safety and performance study, following a single-center prospective and noncomparative.
| Arm | Type | Receives |
|---|---|---|
| MiWEndo + colonoscope | Experimental | Device: MiWEndo SystemAll patients will be explored with MiWEndo as an accessory to colonoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients older than 18-year-old referred for a screening or surveillance colonoscopy because of a high-risk condition of developing colorectal cancer or having colorectal polyps as fecal occult blood test (FOBT) positive, previously resected polyps under surveillance, hereditary polyposis syndromes, Lynch Syndrome or familial cancer.
- These criteria will ensure the probability of finding polyps during the explorations.
- All the patients will give written informed consent.
Key exclusion criteria (3 listed)
- Patients at a high risk of having major complications as perforation or hemorrhage, suspected or proven lower gastrointestinal bleeding, non-correctable coagulopathy or anticoagulant/clopidogrel therapy during procedure, inadequate bowel cleansing.
- ASA-IV patients.
- Urgent colonoscopy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MiWEndo SystemAll 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. | Device | MiWEndo + colonoscope |
Primary outcome
Number of polyps
Time frame: During the procedure.
With MiWEndo assisted colonoscopy, detect at least one polyp before colonoscopy in 10% of patients.
Number of adverse events.
Time frame: 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.
Time frame: During the procedure and up to 2 weeks after.
Mural injuries related with the use of the MiWEndo.
4 secondary outcomes
Number and size (adenomas and polyps).
Time frame: During procedure.
True positives (TP), False positives (FP), False negatives (FN).
Time frame: During procedure.
Patients' comfort.
Time frame: Immediately after the procedure and 2 weeks after.
Perception of difficulty.
Time frame: Immediately after the procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MiWEndo System in people with Colorectal Cancer and Colorectal Polyp, run by MiWEndo Solutions S.L. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of polyps (time frame: During the procedure.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.