Colorectal PolypsNCT07448129
Clinical Trial to Evaluate the Efficacy and Safety of SUBMO® as a Submucosal Injection Agent in Endoscopic Resection of Superficial Gastrointestinal Lesions.
A study testing SUBMO® Submucosal Injection and Normal Saline (0.9% Sodium Chloride) with Surface Dye Injection in people with Colorectal Polyps, run by i+Med S.Coop. at 4 sites in Spain.
Trial summary
The SUBMO-PIC01-2025 study evaluates whether SUBMO®, a submucosal injection hydrogel composed of high-molecular weight hyaluronic acid and methylene blue, is as effective and safe as normal saline for endoscopic resection of superficial colorectal lesions larger than 10 mm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Polyps
- What is being tested?
- SUBMO® Submucosal Injection and Normal Saline (0.9% Sodium Chloride) with Surface Dye Injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 4 sitesSpain
- Study dates
- 29 Apr 2026to Mar 2027
- 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
- Subjects >18 years old.
- Presence of a colorectal lesion larger than 10 mm, confirmed through colonoscopy.
- The lesion must be considered technically resectable using either Endoscopic Mucosal Resection (RME) or Endoscopic Submucosal Dissection (DSE).
- The participant must be willing and able to comply with all required study visits and procedures, according to the protocol.
- The participant must understand, sign, and date the written informed consent form before undergoing any study-specific procedures.
Who cannot join
- Severe comorbidities according to clinical judgment, including patients classified as ASA IV or ASA V, except those ASA IV cases explicitly approved as clinically safe by the center's Anesthesiology Service (using the ASA anesthetic classification).
- Patients presenting some coagulopathy that prevents safe endoscopic resection.
- Lesions that are suspicious endoscopic invasive cancer.
- Any medical condition that, in the investigator's opinion, could compromise patient safety or protocol adherence.
- Known allergy or hypersensitivity to any component of the investigational product, including hyaluronic acid, methylene blue, or any excipients.
- Contraindications to colonoscopy or to the administration of sedation/anesthesia.
- Current participation in another clinical investigation with an investigational product, or participation in any clinical study (with tested or untested products) within the previous 30 days prior to randomization.
- Pregnant or breastfeeding women.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain4 sites, 4 recruiting
- Recruiting
Hospital Universitario de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08026
Jorge Gordillo, Ábalos, 935 565 920, JGordillo@santpau.cat
- Recruiting
Hospital Universitario Basurto
Bilbao, Bizkaia, 48013
Ángel Calderón, Dr, 944 00 60 00, angeljose.calderongarcia@osakidetza.eus
- Recruiting
Hospital de Cruces
Bilbao, Bizkaia, 48903
David Coto, Dr, 946 00 60 00, david.cotougarte@osakidetza.eus
- Recruiting
Hospital Althaia
Manresa, Barcelona, 08243
Marco Antonio Álvarez, Dr, 938 759 300, marcoalgo@gmail.com
About this study
Official title: Randomized Clinical Trial to Evaluate the Efficacy and Safety of the Use of a Medical Device (SUBMO®) for Submucosal Injection in Endoscopic Resection Techniques of Superficial Gastrointestinal Lesions.
The SUBMO-PIC01-2025 study evaluates whether SUBMO®, a submucosal injection hydrogel composed of high-molecular weight hyaluronic acid and methylene blue, is as effective and safe as normal saline for endoscopic resection of superficial colorectal lesions larger than 10 mm. Its primary aim is to determine non-inferiority in complete resection rates, whether en bloc or fragmented, and to assess safety through the systematic identification of serious adverse events. Secondary aims include analysing the total volume of product needed, the number of injections required, the maintenance of the submucosal cushion, the duration of the procedure, the ease of resection, the subjective evaluation of endoscopists, and the appearance of additional adverse events related to the intervention such as intraprocedural bleeding, fever, significant post-procedure pain, post-coagulation syndrome or immediate or delayed perforation.
Eligible participants are adults aged 18 or older with a confirmed colorectal lesion greater than 10 mm that is technically resectable using EMR or ESD, who are capable and willing to follow the study procedures and who have signed informed consent prior to any protocol-specific action. Exclusion criteria include severe comorbidities corresponding to ASA IV or V unless specifically authorised by anaesthesia, coagulopathies that prevent endoscopic resection, endoscopic suspicion of invasive cancer, any condition deemed by investigators to compromise safety or adherence, known allergy to hyaluronic acid, methylene blue or excipients, contraindications to colonoscopy or sedation, participation in another clinical investigation within the previous 30 days, and pregnancy or breastfeeding. Participants may be withdrawn due to voluntary consent withdrawal, safety concerns, protocol deviations that affect data integrity or patient safety, loss to follow-up or pregnancy discovered during the study.
The main efficacy variable is the technical success of resection as judged immediately by the endoscopist, while the main safety variable is the incidence of serious adverse events and their causal relationship with the investigational product. Exploratory variables include baseline demographics such as age, sex, ethnic origin and body mass index, anticoagulant or antiplatelet medication, and comorbidities including endoscopic history, obesity, hypertension, cardiovascular disease, haematologic disorders such as von Willebrand disease or haemophilia, and chronic liver disease. Baseline variables also include ASA classification and lifestyle habits. Polyp-related variables include size, number, anatomical location in the colon or rectum, LST subtype and JNET classification. Resection-related variables capture the technique used (EMR or ESD), whether the resection is en bloc or piecemeal, the number of fragments for calculating the Sydney Resection Quotient, the DMI score and any closure technique or complications. Treatment-related variables include total and per-surface area injection volume, number of submucosal injections needed, macroscopic evaluation of cushion maintenance, total procedure time, ease of resection using a visual analogue scale from 0 to 100, a usability questionnaire completed by the endoscopists and a detailed record of all adverse events including bleeding, fever, pain, post-coagulation syndrome and perforation.
- Conditions
- Colorectal Polyps
- Being tested
- SUBMO® Submucosal Injection, Normal Saline (0.9% Sodium Chloride) with Surface Dye Injection
- Keywords
- Submucosal injection, endoscopic resection, hyaluronic acid hydrogel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUBMO® Submucosal InjectionDevice
Participants randomized to this arm undergo endoscopic resection (EMR or ESD) in which the submucosal injection is performed using SUBMO®, a high-viscosity hydrogel composed of high-molecular-weight hyaluronic acid and methylene blue. SUBMO® is administered through a standard injection needle to create and maintain a stable submucosal cushion that facilitates safe and complete resection of colorectal lesions. Its integrated dye enhances visualization of the submucosal layer. All other aspects of the procedure follow routine clinical practice.
Normal Saline (0.9% Sodium Chloride) with Surface Dye InjectionDevice
Participants in this arm undergo endoscopic resection using normal saline as the submucosal injection solution, combined with surface dye staining (methylene blue or indigo carmine) prepared as customary in hospital practice, ensuring visibility equivalent to that of the experimental product. Saline is injected to raise the mucosa and allow resection, following standard EMR or ESD clinical techniques. This arm represents the current standard of care for submucosal injection in colorectal lesion resection.
| Study group | Role | What they receive |
|---|---|---|
| SUBMO® Submucosal Injection | Experimental | SUBMO® is a sterile, pyrogen-free hydrogel composed of high-molecular-weight sodium hyaluronate combined with methylene blue and buffered salts in an isotonic, physiological-pH solution. It is designed to act as a submucosal filler, creating a stable and long-lasting elevation between mucosal and muscular layers. The formulation provides structural support due to its viscosity and enhances visualization through integrated methylene blue. SUBMO® is supplied in 10 mL prefilled borosilicate glass syringes and is classified as a Class III medical device without CE marking. Receives: Device: SUBMO® Submucosal Injection |
| Normal Saline (0.9% Sodium Chloride) with Surface Dye Injection | Active comparator | The control product is 0.9% sodium chloride solution (normal saline), used as a standard, low-viscosity submucosal injection fluid. To ensure visualization comparable to the experimental product, a non-infused surface dye such as methylene blue or indigo carmine is added according to routine hospital practice. Saline provides a short-lasting mucosal lift and does not contain structural polymers or integrated colorants. It represents the current reference solution widely used for submucosal elevation. Receives: Device: Normal Saline (0.9% Sodium Chloride) with Surface Dye Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resection (RME / ESD) Technical Success
Resection technical success represents the immediate procedural success of the endoscopist in achieving a complete resection of the target lesion. Assessment is based on the endoscopist's expert judgement of whether the entire lesion has been removed, following either EMR (Endoscopic Mucosal Resection) or ESD (Endoscopic Submucosal Dissection). The result is recorded dichotomously (success / no success). At the end of the study, this outcome will be expressed as the percentage of patients in each treatment arm who achieved complete resection.
Measured: Immediatly after procedure (day 0)
Incidence and Characterisation of Serious Adverse Events (SAEs)
This is the primary safety outcome and includes all serious adverse events occurring from the moment a patient receives the investigational or control product until the end of follow-up.
Measured: Throughout the study (from day 0 to 1 month)
Secondary outcomes (11)
Total size of the lesion (mm)
Measurement of the total size of the lesion (the largest lesion will be used as reference in the measurement) (measured in millimeters).
Measured: During intervention (day 0)
Number of lesions (>10 mm)
Measurement of the number of lesions larger than 10 mm.
Measured: During intervention (day 0)
Anatomical location of the lesion
Description of the anatomical location within the colon or rectum (right colon, transverse colon, left colon, or rectum).
Measured: During intervention (day 0)
LST (Lateral Spreading Tumor) classification
Classification of the polyps that spread laterally across de mucosa, it predicts the risk of the submucosa infiltration.
The classification will be divided into two groups: Granular polyps (LST-G) and Non-Granular polyps (LST-NG)
Measured: During intervention (day 0)
JNET (Japanese NBI Expert Team) classification
Classification that divides NICE 2 lesions into 2 groups: 2A (low grade adenomas) and 2B (high grade adenomas, incorporating the cancers that infiltrate the submucosa superficially)
Measured: During intervention (day 0)
Resection Technique
Resection technique used (EMR vs. ESD).
Fragmentation data are used to calculate the Sydney Resection Quotient, a metric reflecting resection efficiency and difficulty (lesion size divided by number of fragments).
Measured: During intervention (Day 0)
Analysis of lesion removal (single piece removal vs. multiple fragments removal)
Analysis of the outcome of the resection measure as wether the lesion was removed in a single piece or multiple fragments.
Sydney Resection Quotient is calculated for the multiple fragment removal, a metric reflecting resection efficiency and difficulty (lesion size divided by number of fragments).
Measured: During intervention (Day 0)
Number of Fragments collected
Analysis of the number of fragments collected when piecemeal resection occurs.
Fragmentation data are used to calculate the Sydney Resection Quotient, a metric reflecting resection efficiency and difficulty (lesion size divided by number of fragments).
Measured: During intervention (Day 0)
Sydney Deep Mural Injury Score (DMI)
Analysis of the Sydney Deep Mural Injury (DMI) score (0 to IV points), which assesses the depth of tissue injury (0-Normal defect; IV-actual hole with a white cautery ring).
Measured: During intervention (Day 0)
Closure Techniques vs. Hemostatic measures
Documentation of whether closure techniques or hemostatic measures were applied (such as clipping, coagulation, or other methods).
Measured: During intervention (Day 0)
Intra-procedural complications
Data on intra-procedural complications, whether minor or significant, are recorded.
Measured: During intervention (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start29 Apr 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal PolypsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- i+Med S.Coop.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Universitario Basurto, Hospital de Cruces, Hospital Sant Joan de Deu, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Responsible party
- Sponsor
- Investigators
- Angel Calderón, Dr, Principal investigator, Hospital Universitario Basurto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07448129
- Sponsor's protocol ID
- SUBMO-PIC01-2025
- Status last verified
- Jul 2026
- First submitted
- 26 Feb 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- 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 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial to Evaluate the Efficacy and Safety of the Use of a Medical Device (SUBMO®) for Submucosal Injection in Endoscopic Resection Techniques of Superficial Gastrointestinal Lesions.
- ClinicalTrials.gov ID
- NCT07448129
- Acronym / sponsor ID
- SUBMO-PIC01-2025
- Conditions
- Colorectal Polyps
- Keywords
- Submucosal injection, endoscopic resection, hyaluronic acid hydrogel
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- i+Med S.Coop.Industry (pharma, biotech, devices)
- Collaborators
- Hospital Universitario Basurto, Hospital de Cruces, Hospital Sant Joan de Deu, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Study start
- 29 Apr 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 4 Mar 2026 (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 SUBMO-PIC01-2025 study evaluates whether SUBMO®, a submucosal injection hydrogel composed of high-molecular weight hyaluronic acid and methylene blue, is as effective and safe as normal saline for endoscopic resection of superficial colorectal lesions larger than 10 mm. Its primary aim is to determine non-inferiority in complete resection rates, whether en bloc or fragmented, and to assess safety through the systematic identification of serious adverse events. Secondary aims include analysing the total volume of product needed, the number of injections required, the maintenance of the submucosal cushion, the duration of the procedure, the ease of resection, the subjective evaluation of endoscopists, and the appearance of additional adverse events related to the intervention such as intraprocedural bleeding, fever, significant post-procedure pain, post-coagulation syndrome or immediate or delayed perforation.
Eligible participants are adults aged 18 or older with a confirmed colorectal lesion greater than 10 mm that is technically resectable using EMR or ESD, who are capable and willing to follow the study procedures and who have signed informed consent prior to any protocol-specific action. Exclusion criteria include severe comorbidities corresponding to ASA IV or V unless specifically authorised by anaesthesia, coagulopathies that prevent endoscopic resection, endoscopic suspicion of invasive cancer, any condition deemed by investigators to compromise safety or adherence, known allergy to hyaluronic acid, methylene blue or excipients, contraindications to colonoscopy or sedation, participation in another clinical investigation within the previous 30 days, and pregnancy or breastfeeding. Participants may be withdrawn due to voluntary consent withdrawal, safety concerns, protocol deviations that affect data integrity or patient safety, loss to follow-up or pregnancy discovered during the study.
The main efficacy variable is the technical success of resection as judged immediately by the endoscopist, while the main safety variable is the incidence of serious adverse events and their causal relationship with the investigational product. Exploratory variables include baseline demographics such as age, sex, ethnic origin and body mass index, anticoagulant or antiplatelet medication, and comorbidities including endoscopic history, obesity, hypertension, cardiovascular disease, haematologic disorders such as von Willebrand disease or haemophilia, and chronic liver disease. Baseline variables also include ASA classification and lifestyle habits. Polyp-related variables include size, number, anatomical location in the colon or rectum, LST subtype and JNET classification. Resection-related variables capture the technique used (EMR or ESD), whether the resection is en bloc or piecemeal, the number of fragments for calculating the Sydney Resection Quotient, the DMI score and any closure technique or complications. Treatment-related variables include total and per-surface area injection volume, number of submucosal injections needed, macroscopic evaluation of cushion maintenance, total procedure time, ease of resection using a visual analogue scale from 0 to 100, a usability questionnaire completed by the endoscopists and a detailed record of all adverse events including bleeding, fever, pain, post-coagulation syndrome and perforation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SUBMO® Submucosal Injection | Experimental | Device: SUBMO® Submucosal InjectionSUBMO® is a sterile, pyrogen-free hydrogel composed of high-molecular-weight sodium hyaluronate combined with methylene blue and buffered salts in an isotonic, physiological-pH solution. It is designed to act as a submucosal filler, creating a stable and long-lasting elevation between mucosal and muscular layers. The formulation provides structural support due to its viscosity and enhances visualization through integrated methylene blue. SUBMO® is supplied in 10 mL prefilled borosilicate glass syringes and is classified as a Class III medical device without CE marking. |
| Normal Saline (0.9% Sodium Chloride) with Surface Dye Injection | Active comparator | Device: Normal Saline (0.9% Sodium Chloride) with Surface Dye InjectionThe control product is 0.9% sodium chloride solution (normal saline), used as a standard, low-viscosity submucosal injection fluid. To ensure visualization comparable to the experimental product, a non-infused surface dye such as methylene blue or indigo carmine is added according to routine hospital practice. Saline provides a short-lasting mucosal lift and does not contain structural polymers or integrated colorants. It represents the current reference solution widely used for submucosal elevation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects >18 years old.
- Presence of a colorectal lesion larger than 10 mm, confirmed through colonoscopy.
- The lesion must be considered technically resectable using either Endoscopic Mucosal Resection (RME) or Endoscopic Submucosal Dissection (DSE).
- The participant must be willing and able to comply with all required study visits and procedures, according to the protocol.
- The participant must understand, sign, and date the written informed consent form before undergoing any study-specific procedures.
Key exclusion criteria (8 listed)
- Severe comorbidities according to clinical judgment, including patients classified as ASA IV or ASA V, except those ASA IV cases explicitly approved as clinically safe by the center's Anesthesiology Service (using the ASA anesthetic classification).
- Patients presenting some coagulopathy that prevents safe endoscopic resection.
- Lesions that are suspicious endoscopic invasive cancer.
- Any medical condition that, in the investigator's opinion, could compromise patient safety or protocol adherence.
- Known allergy or hypersensitivity to any component of the investigational product, including hyaluronic acid, methylene blue, or any excipients.
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 |
|---|---|---|
| SUBMO® Submucosal InjectionParticipants randomized to this arm undergo endoscopic resection (EMR or ESD) in which the submucosal injection is performed using SUBMO®, a high-viscosity hydrogel composed of high-molecular-weight hyaluronic acid and methylene blue. SUBMO® is administered through a standard injection needle to create and maintain a stable submucosal cushion that facilitates safe and complete resection of colorectal lesions. Its integrated dye enhances visualization of the submucosal layer. All other aspects of the procedure follow routine clinical practice. | Device | SUBMO® Submucosal Injection |
| Normal Saline (0.9% Sodium Chloride) with Surface Dye InjectionParticipants in this arm undergo endoscopic resection using normal saline as the submucosal injection solution, combined with surface dye staining (methylene blue or indigo carmine) prepared as customary in hospital practice, ensuring visibility equivalent to that of the experimental product. Saline is injected to raise the mucosa and allow resection, following standard EMR or ESD clinical techniques. This arm represents the current standard of care for submucosal injection in colorectal lesion resection. | Device | Normal Saline (0.9% Sodium Chloride) with Surface Dye Injection |
Primary outcome
Resection (RME / ESD) Technical Success
Time frame: Immediatly after procedure (day 0)
Resection technical success represents the immediate procedural success of the endoscopist in achieving a complete resection of the target lesion. Assessment is based on the endoscopist's expert judgement of whether the entire lesion has been removed, following either EMR (Endoscopic Mucosal Resection) or ESD (Endoscopic Submucosal Dissection). The result is recorded dichotomously (success / no success). At the end of the study, this outcome will be expressed as the percentage of patients in each treatment arm who achieved complete resection.
Incidence and Characterisation of Serious Adverse Events (SAEs)
Time frame: Throughout the study (from day 0 to 1 month)
This is the primary safety outcome and includes all serious adverse events occurring from the moment a patient receives the investigational or control product until the end of follow-up.
11 secondary outcomes
Total size of the lesion (mm)
Time frame: During intervention (day 0)
Number of lesions (>10 mm)
Time frame: During intervention (day 0)
Anatomical location of the lesion
Time frame: During intervention (day 0)
LST (Lateral Spreading Tumor) classification
Time frame: During intervention (day 0)
JNET (Japanese NBI Expert Team) classification
Time frame: During intervention (day 0)
Resection Technique
Time frame: During intervention (Day 0)
Analysis of lesion removal (single piece removal vs. multiple fragments removal)
Time frame: During intervention (Day 0)
Number of Fragments collected
Time frame: During intervention (Day 0)
Sydney Deep Mural Injury Score (DMI)
Time frame: During intervention (Day 0)
Closure Techniques vs. Hemostatic measures
Time frame: During intervention (Day 0)
Intra-procedural complications
Time frame: During intervention (Day 0)
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 9 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Colorectal Polyps
Recruiting
Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps
Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum
Recruiting
Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology
Colonic Neoplasms
RecruitingObservational study
KLF4 Epigenetic Modulation
KLF4 Methylation, Epigenetic
RecruitingObservational study
Malignant Polyp Registry
Malignant Colorectal Polyp, Colorectal Cancer
Not yet recruiting
Social Software-Based Intelligent Management System for Bowel Preparation
Colorectal Polyp, Colorectal Adenoma
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.
Angel Calderón, Dr principal investigator
Hospital Universitario Basurto
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SUBMO® Submucosal Injection and Normal Saline (0.9% Sodium Chloride) with Surface Dye Injection in people with Colorectal Polyps, run by i+Med S.Coop. at 4 sites 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 5 inclusion and 8 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 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Contact Josune Torrecilla (+34945561134, jtorrecilla@imasmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resection (RME / ESD) Technical Success (time frame: Immediatly after procedure (day 0)). The study lists 2 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 9 Jul 2026.