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| Name | Class |
|---|---|
| Hospital Torrecárdenas, Almería, Spain | UNKNOWN |
| Hospital Poniente, El Ejido, Almería, Spain | UNKNOWN |
| Hospitales Universitarios Virgen del Rocío | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From administration up to 120 minutes post-injection |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Every 5 minutes up to 120 minutes post-injection |
| Local adverse reactions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose Antonio Morales Molina, PhD in Pharmacy | Pharmacy Department, Torrecárdenas Hospital, 04009 Almería, Spain | Study Director |
| Jose Antonio Morales Molina, PhD in Pharmacy | Pharmacy Department, Torrecárdenas Hospital, 04009 Almería, Spain | Principal Investigator |
| Sergio Ángel Requejo | NAKAFARMA SL | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Torrecárdenas | Almería | Almería | 04009 | Spain |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Hospital de Baza, Granada, Spain |
| UNKNOWN |
| Hospital Virgen de Valme, Seville, Spain | UNKNOWN |
| Quirónsalud, Málaga, Spain | UNKNOWN |
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
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This study is a double-blind, randomized clinical trial, meaning that participants and investigators are unaware of the treatment allocation. The investigational solution and the comparator (placebo or treatment) are identical in appearance, volume, and administration method to ensure blinding. Unblinding will only occur in cases of medical necessity.
| 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. |
|
Number of participants experiencing local adverse reactions, evaluated through clinical inspection and classified according to the CTCAE v4.0 scale.
| Up to 6 months post-injection |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |