Colorectal CancerMiWEndo1NCT05477836
Feasibility and Safety of MiWEndo-assisted Colonoscopy
A study testing MiWEndo-assisted colonoscopy 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 a small group of patients to assess the preliminary safety of its use and lack of normal clinical practice modification. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Colorectal Cancer, Colorectal Polyp, Colorectal Adenoma
- What is being tested?
- MiWEndo-assisted colonoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- 18 Oct 2022to 25 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women older than 50 years referred for a diagnostic or surveillance colonoscopy and having signed the Informed Consent Form.
Who cannot join
- 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 colectomy, acute diverticulitis, 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Safety of MiWEndo-assisted Colonoscopy:Pilot Study
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).
Read the detailed description
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.
- Conditions
- Colorectal Cancer, Colorectal Polyp, Colorectal Adenoma, Colorectal Neoplasms, Colorectal Adenomatous Polyp, Colorectal Adenocarcinoma
- Being tested
- MiWEndo-assisted colonoscopy
- 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-assisted colonoscopyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Microwave-based colonoscopy Receives: Device: MiWEndo-assisted colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of incidents and adverse events
To assess the safety of MiWEndo colonoscopy using the lexicon proposed by the American Society of Gastrointestinal Endoscopy (ASGE).
Measured: During the procedure and up to 2 weeks after
Number of mural injuries
To assess the safety of MiWEndo colonoscopy according to the Sydney classification for deep mural injuries (DMI)
Measured: During the procedure
Rate of cecal intubation
To assess the feasibility of performing a complete colonoscopy using the MiWEndo System. This parameter will be measured as complete colonoscopy (yes/no).
Measured: During the procedure
Length of colon explored
In case cecum could not be reached, the distance will be measured (in cm).
Measured: During the procedure
Secondary outcomes (4)
Patients' comfort
Subjective assessment from patient following the Gloucester 5-Likert scale, where 1 is no discomfort and 5 is extreme discomfort.
Measured: Immediately after the procedure and 2 weeks after
Time for reaching the cecum (or maximum explored colon length)
Measured in minutes
Measured: During the procedure
Total time for completing the procedure
Measured in minutes
Measured: Immediately after the procedure
Perception of difficulty
Difficulty by the endoscopist subjectively assessed based on a 5-points Likert scale, where 0 is not difficult and 4 is very difficult.
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 posted28 Jul 2022
- Study start18 Oct 2022
- Primary completion25 Nov 2022
- Study completion25 Nov 2022
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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Traditional feasibility study, following a single-center prospective, non-comparative, with few patients design.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- MiWEndo Solutions S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Clinic of Barcelona
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05477836
- Sponsor's protocol ID
- DO-021_CIP1
- Acronym
- MiWEndo1
- Status last verified
- Nov 2022
- First submitted
- 21 Jul 2022
- Last updated
- 30 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety of MiWEndo-assisted Colonoscopy:Pilot Study
- ClinicalTrials.gov ID
- NCT05477836
- Acronym / sponsor ID
- MiWEndo1 / DO-021_CIP1
- Conditions
- Colorectal Cancer, Colorectal Polyp, Colorectal Adenoma, Colorectal Neoplasms, Colorectal Adenomatous Polyp, Colorectal Adenocarcinoma
- Keywords
- microwave imaging, colonoscopy, early diagnosis, colorectal cancer screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- MiWEndo Solutions S.L.Industry (pharma, biotech, devices)
- Collaborators
- Hospital Clinic of Barcelona
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 25 Nov 2022 (actual)
- Study completion
- 25 Nov 2022 (actual)
- First posted
- 28 Jul 2022 (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 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).
Detailed description
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Traditional feasibility study, following a single-center prospective, non-comparative, with few patients design.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: MiWEndo-assisted colonoscopyMicrowave-based colonoscopy |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men and women older than 50 years referred for a diagnostic or surveillance colonoscopy and having signed the Informed Consent Form.
Key exclusion criteria (3 listed)
- 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 colectomy, acute diverticulitis, 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
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-assisted colonoscopyAll 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. | Device | Experimental group |
Primary outcome
Number of incidents and adverse events
Time frame: During the procedure and up to 2 weeks after
To assess the safety of MiWEndo colonoscopy using the lexicon proposed by the American Society of Gastrointestinal Endoscopy (ASGE).
Number of mural injuries
Time frame: During the procedure
To assess the safety of MiWEndo colonoscopy according to the Sydney classification for deep mural injuries (DMI)
Rate of cecal intubation
Time frame: During the procedure
To assess the feasibility of performing a complete colonoscopy using the MiWEndo System. This parameter will be measured as complete colonoscopy (yes/no).
Length of colon explored
Time frame: During the procedure
In case cecum could not be reached, the distance will be measured (in cm).
4 secondary outcomes
Patients' comfort
Time frame: Immediately after the procedure and 2 weeks after
Time for reaching the cecum (or maximum explored colon length)
Time frame: During the procedure
Total time for completing the procedure
Time frame: Immediately after the procedure
Perception of difficulty
Time frame: Immediately after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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-assisted colonoscopy 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 1 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: finished, as of the sponsor's last update on 30 Nov 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of incidents and adverse events (time frame: During the procedure and up to 2 weeks after). The study lists 4 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 30 Nov 2022.