Endoscopic Mucosal ResectionPhase 3NCT06910514
Efficacy and Safety of a Solution for Endoscopic Mucosal Resection of Colonic Lesions
A Phase 3 study testing Mucopolysaccharide saline solution 0.9% and Saline solution 0.9% in people with Endoscopic Mucosal Resection and Colonic Neoplasms, run by Nakafarma S.L. at 1 site in Spain.
Trial summary
The objetive of this clinical trial is to evaluate the efficacy and safety of a solution for endoscopic mucosal resection of colonic lesions in patients undergoing endoscopic resection procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endoscopic Mucosal Resection, Colonic Neoplasms, Therapeutic Irrigation
- What is being tested?
- Mucopolysaccharide saline solution 0.9% and Saline solution 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteSpain
- Study dates
- 18 Jan 2021to 23 Dec 2022
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of any sex, >18 years old, diagnosed with sessile or flat polyps, with a diameter greater than or equal to 2 cm, in the intestinal submucosa by the Endoscopy Unit.
- The subject has understood and signed an informed consent form (ICF) approved by a Research Ethics Committee (REC) before any study evaluation and commits to completing the study as defined in the protocol.
- Not undergoing active treatment with antiplatelet or anticoagulant drugs.
- After signing the informed consent, patients are scheduled for lesion resection within <3 months from their diagnosis.
Who cannot join
- Patients with documented allergy to any of the components of the mucosectomy solution or drugs used in sedation.
- Pregnant women.
- Patients on contraceptive treatment or post-menopausal.
- Hematological disorders with uncorrected coagulation abnormalities, with an INR >= 1.5, or patients undergoing active treatment with antiplatelet or anticoagulant drugs.
- Patients with intestinal perforation or obstruction, toxic megacolon, diverticulitis, or inflammatory bowel disease.
- Patients with previous partial resection or pending resection.
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- Patients with lesions classified as Paris type III and/or invasive intestinal carcinoma and/or metastases. Patients with previous treatment of the lesion (radiotherapy, endoscopic, surgical, chemotherapy).
- Patients included in another study during the previous month.
- Conditions that, in the medical judgment, contraindicate polyp removal.
- Absence of a signed informed consent, non-acceptance, or contraindication of surgical or anesthetic techniques (Patients with ASA status: High anesthetic risk (ASA score > 3)) and difficulty in the patient's understanding of the conditions of the endoscopic procedure.
- Endoscopic appearance of invasive malignancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter, Randomized, Double-Blind Clinical Trial on the Efficacy and Safety of a Solution for Endoscopic Mucosal Resection of Colonic Lesions
The objetive of this clinical trial is to evaluate the efficacy and safety of a solution for endoscopic mucosal resection of colonic lesions in patients undergoing endoscopic resection procedures.
The main questions it aims to answer are:
Read more
Does the investigational solution improve the efficacy of endoscopic mucosal resection compared to standard practice? Is the investigational solution safe for use in colonic lesion resection procedures?
Researchers will compare the investigational solution (Demirex) to a standard or placebo solution to see if it improves procedural outcomes and safety profiles.
Participants will undergo endoscopic mucosal resection using either the investigational solution or the comparator, and will be monitored for procedural success, safety, and any adverse events.
- Conditions
- Endoscopic Mucosal Resection, Colonic Neoplasms, Therapeutic Irrigation, Treatment Outcome
- Being tested
- Mucopolysaccharide saline solution 0.9%, Saline solution 0.9%
- Keywords
- DEMIREX
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mucopolysaccharide saline solution 0.9%Combination product
Injectable solution designed for submucosal elevation in endoscopic mucosal resection. Administered via submucosal injection prior to polyp resection, adding 1% indigo carmine before administration.
Saline solution 0.9%Combination product
Control injectable solution composed of saline 0.9 %. Administered via submucosal injection prior to polyp resection, adding 1% indigo carmine before administration.
| Study group | Role | What they receive |
|---|---|---|
| Saline solution 0.9% | Placebo comparator | This arm of the study serves as the placebo comparator, where participants will receive a sterile saline solution administered under the same conditions as the experimental treatment. The saline solution does not contain the active ingredient being studied and will be used to evaluate the efficacy and safety of the experimental treatment in comparison to the control group. Receives: Combination Product: Saline solution 0.9% |
| DEMIREX | Experimental | This arm of the study serves as the experimental treatment group, where participants will receive a study solution administered under conditions intended to facilitate endoscopic mucosal resection of colonic lesions. This experimental arm aims to evaluate the efficacy and safety of this novel solution (Demirex) for the endoscopic resection of mucosal lesions in the colon with a diameter of ≥2 cm Receives: Combination Product: Mucopolysaccharide saline solution 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistence of the compound in the submucosa
Duration for which the injected compound remains visible in the submucosa, assessed through clinical observation and imaging techniques.
Measured: From administration up to 120 minutes post-injection
Secondary outcomes (2)
Effective duration of the wheal
Time in minutes during which the wheal remains visible and measurable after the compound injection, assessed using a digital caliper.
Measured: Every 5 minutes up to 120 minutes post-injection
Local adverse reactions
Number of participants experiencing local adverse reactions, evaluated through clinical inspection and classified according to the CTCAE v4.0 scale.
Measured: Up to 6 months post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start18 Jan 2021
- Primary completion23 Dec 2022
- Study completion23 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endoscopic Mucosal ResectionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, Randomized, Double-Blind Clinical Trial with a 4:1 Allocation on the Efficacy and Safety of a Solution for Endoscopic Mucosal Resection of Colonic Lesions
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nakafarma S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Torrecárdenas, Almería, Spain, Hospital Poniente, El Ejido, Almería, Spain, Hospitales Universitarios Virgen del Rocío, Hospital de Baza, Granada, Spain, Hospital Virgen de Valme, Seville, Spain, Quirónsalud, Málaga, Spain
- Responsible party
- Sponsor
- Investigators
- Jose Antonio Morales Molina, PhD in Pharmacy, Study director, Pharmacy Department, Torrecárdenas Hospital, 04009 Almería, SpainJose Antonio Morales Molina, PhD in Pharmacy, Principal investigator, Pharmacy Department, Torrecárdenas Hospital, 04009 Almería, SpainSergio Ángel Requejo, Study chair, NAKAFARMA SL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06910514
- Sponsor's protocol ID
- DEMI-2019-01
- Status last verified
- Mar 2025
- First submitted
- 7 Mar 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-Blind Clinical Trial on the Efficacy and Safety of a Solution for Endoscopic Mucosal Resection of Colonic Lesions
- ClinicalTrials.gov ID
- NCT06910514
- Acronym / sponsor ID
- DEMI-2019-01
- Conditions
- Endoscopic Mucosal Resection, Colonic Neoplasms, Therapeutic Irrigation, Treatment Outcome
- Keywords
- DEMIREX
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Nakafarma S.L.Industry (pharma, biotech, devices)
- Collaborators
- Hospital Torrecárdenas, Almería, Spain, Hospital Poniente, El Ejido, Almería, Spain, Hospitales Universitarios Virgen del Rocío, Hospital de Baza, Granada, Spain, Hospital Virgen de Valme, Seville, Spain, Quirónsalud, Málaga, Spain
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 23 Dec 2022 (actual)
- Study completion
- 23 Dec 2022 (actual)
- First posted
- 4 Apr 2025 (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 objetive of this clinical trial is to evaluate the efficacy and safety of a solution for endoscopic mucosal resection of colonic lesions in patients undergoing endoscopic resection procedures.
The main questions it aims to answer are:
Does the investigational solution improve the efficacy of endoscopic mucosal resection compared to standard practice? Is the investigational solution safe for use in colonic lesion resection procedures?
Researchers will compare the investigational solution (Demirex) to a standard or placebo solution to see if it improves procedural outcomes and safety profiles.
Participants will undergo endoscopic mucosal resection using either the investigational solution or the comparator, and will be monitored for procedural success, safety, and any adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Multicenter, Randomized, Double-Blind Clinical Trial with a 4:1 Allocation on the Efficacy and Safety of a Solution for Endoscopic Mucosal Resection of Colonic Lesions
| Arm | Type | Receives |
|---|---|---|
| Saline solution 0.9% | Placebo comparator | Combination Product: Saline solution 0.9%This arm of the study serves as the placebo comparator, where participants will receive a sterile saline solution administered under the same conditions as the experimental treatment. The saline solution does not contain the active ingredient being studied and will be used to evaluate the efficacy and safety of the experimental treatment in comparison to the control group. |
| DEMIREX | Experimental | Combination Product: Mucopolysaccharide saline solution 0.9%This arm of the study serves as the experimental treatment group, where participants will receive a study solution administered under conditions intended to facilitate endoscopic mucosal resection of colonic lesions. This experimental arm aims to evaluate the efficacy and safety of this novel solution (Demirex) for the endoscopic resection of mucosal lesions in the colon with a diameter of ≥2 cm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients of any sex, >18 years old, diagnosed with sessile or flat polyps, with a diameter greater than or equal to 2 cm, in the intestinal submucosa by the Endoscopy Unit.
- The subject has understood and signed an informed consent form (ICF) approved by a Research Ethics Committee (REC) before any study evaluation and commits to completing the study as defined in the protocol.
- Not undergoing active treatment with antiplatelet or anticoagulant drugs.
- After signing the informed consent, patients are scheduled for lesion resection within <3 months from their diagnosis.
Key exclusion criteria (11 listed)
- Patients with documented allergy to any of the components of the mucosectomy solution or drugs used in sedation.
- Pregnant women.
- Patients on contraceptive treatment or post-menopausal.
- Hematological disorders with uncorrected coagulation abnormalities, with an INR >= 1.5, or patients undergoing active treatment with antiplatelet or anticoagulant drugs.
- Patients with intestinal perforation or obstruction, toxic megacolon, diverticulitis, or inflammatory bowel disease.
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 |
|---|---|---|
| Mucopolysaccharide saline solution 0.9%Injectable solution designed for submucosal elevation in endoscopic mucosal resection. Administered via submucosal injection prior to polyp resection, adding 1% indigo carmine before administration. | Combination product | DEMIREX |
| Saline solution 0.9%Control injectable solution composed of saline 0.9 %. Administered via submucosal injection prior to polyp resection, adding 1% indigo carmine before administration. | Combination product | Saline solution 0.9% |
Primary outcome
Persistence of the compound in the submucosa
Time frame: From administration up to 120 minutes post-injection
Duration for which the injected compound remains visible in the submucosa, assessed through clinical observation and imaging techniques.
2 secondary outcomes
Effective duration of the wheal
Time frame: Every 5 minutes up to 120 minutes post-injection
Local adverse reactions
Time frame: Up to 6 months post-injection
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 9 Apr 2025.
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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.
Jose Antonio Morales Molina, PhD in Pharmacy study director
Pharmacy Department, Torrecárdenas Hospital, 04009 Almería, Spain
Jose Antonio Morales Molina, PhD in Pharmacy principal investigator
Pharmacy Department, Torrecárdenas Hospital, 04009 Almería, Spain
Sergio Ángel Requejo study chair
NAKAFARMA SL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mucopolysaccharide saline solution 0.9% and Saline solution 0.9% in people with Endoscopic Mucosal Resection and Colonic Neoplasms, run by Nakafarma 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 4 inclusion and 11 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 9 Apr 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Persistence of the compound in the submucosa (time frame: From administration up to 120 minutes post-injection). 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 Apr 2025.