Esophageal NeoplasmsNCT06077981
Comparison of 0.4% Hyaluronic Acid Solution Versus Hydroxyethylamide Solution in Submucosal Endoscopic Resections
A study testing Submucous Endoscopic Dissection with hydroxyethylamide and Submucous Endoscopic Dissection with Hyaluronic acid (TS-905 Blue Eye) in people with Esophageal Neoplasms and Endoscopic Mucosal Resection, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
Trial summary
This is a randomized, single-center clinical trial that will compare the efficacy of two substances used in the submucosal cushion formation stage of endoscopic submucosal resections of early esophageal malignant neoplasms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Neoplasms, Endoscopic Mucosal Resection, Hyaluronic Acid
- What is being tested?
- Submucous Endoscopic Dissection with hydroxyethylamide and Submucous Endoscopic Dissection with Hyaluronic acid (TS-905 Blue Eye)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 19 Jun 2023to 15 Jan 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
- Patients over 18 years of age
- Superficial esophageal adenocarcinoma or squamous cell carcinoma with indication of ESD after discussion in a multidisciplinary oncological board
- Signed informed consent form
Who cannot join
- Residual or recurrent esophageal lesions
- Ulcerated esophageal lesions
- Patients with severe cardiovascular, kidney or liver disease
- History of hypersensitivity to hyaluronic acid
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Instituto do Câncer do Estado de São Paulo
São Paulo, São Paulo, 01246-000
Fauze Maluf-Filho, PhD, +5511991919014, fauze.maluf@terra.com.br
About this study
Official title: Comparison of 0.4% Hyaluronic Acid Solution Versus Hydroxyethylamide Solution in Submucosal Endoscopic Resections of Superficial Malignant Esophageal Neoplasms: a Randomized Clinical Trial.
This is a randomized, single-center clinical trial that will compare the efficacy of two substances used in the submucosal cushion formation stage of endoscopic submucosal resections of early esophageal malignant neoplasms. Such substances are hyaluronic acid in the form of TS-905 Blue Eyeₒ and hydroxyethylamide (Voluven®).
Read the detailed description
- Design of the study: This is a randomized clinical trial in a single center. The lesions will be randomized into three blocks based on the diameter of the largest axis (less than 3 cm, between 3 - 5 cm and greater than 5 cm).
- Selection of patients: The population studied will be patients with early esophageal neoplasia diagnosed and/or referred for submucosal endoscopic dissection at the São Paulo Cancer Institute (ICESP), University of São Paulo.
- Evaluation of effectiveness and definitions:
Effectiveness will be measured from the degree of usefulness. The degree of utility will be determined from two variables: obtaining or not a complete block resection and additional number of submucosal injections performed during endoscopic dissection. The solution that results in a complete block resection with a number of additional injections of 0 (excellent utility degree) or 1 (good utility degree) will be considered effective.
- Being tested
- Submucous Endoscopic Dissection with hydroxyethylamide, Submucous Endoscopic Dissection with Hyaluronic acid (TS-905 Blue Eye)
- Keywords
- Esophageal Neoplasms, Endoscopic Mucosal Resection, Hyaluronic Acid
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Submucous Endoscopic Dissection with hydroxyethylamideProcedure or surgery
The resection will be performed in three stages using hydroxyethylamide : delimitation, incision and dissection. Initially we will inject the hydroxyethylamide and examine the delimitation of the lesion. With Knife itself, using soft or Forced coagulation current, we will circumvent the limits of the lesion with punctual coagulations 5 mm away from it.
Submucous Endoscopic Dissection with Hyaluronic acid (TS-905 Blue Eye)Procedure or surgery
The resection will be performed in three stages using Hyaluronic acid (TS-905 Blue Eye) : delimitation, incision and dissection. Initially we will inject the Blue-Eyed and examine the delimitation of the lesion. With Knife itself, using soft or Forced coagulation current, we will circumvent the limits of the lesion with punctual coagulations 5 mm away from it.
| Study group | Role | What they receive |
|---|---|---|
| Hydroxyethylamide Group | Active comparator | 15 will be from the hydroxyethylamide Group, where the submucosal endoscopic dissection will be performed with submucosal injection of hydroxyethylamide. Receives: Procedure: Submucous Endoscopic Dissection with hydroxyethylamide |
| Hyaluronic acid group (TS-905 Blue Eye) | Active comparator | 15 will be from the Hyaluronic acid group (TS-905 Blue Eye), where the submucosal endoscopic dissection with submucosal injection of hyaluronic acid (TS-905 Blue Eye) will be performed. Receives: Procedure: Submucous Endoscopic Dissection with Hyaluronic acid (TS-905 Blue Eye) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of solution
Compare the volume of TS-905 Blue Eye versus the solution of hydroxyethylamide used.
Measured: During the procedure
Secondary outcomes (2)
Procedure duration in minutes
Evaluate how the procure lasts using each one of the solutions
Measured: During the procedure
Number of additional injections
Evaluate the number of additional injections need to complete the lesion ressection
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start19 Jun 2023
- Primary completion30 Dec 2024
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal NeoplasmsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization shall consist of 30 patients, of which: 15 will be from the hydroxyethylamide Group, where the submucosal endoscopic dissection will be performed with submucosal injection of hydroxyethylamide. 15 will be from the Hyaluronic acid group (TS-905 Blue Eye), where the submucosal endoscopic dissection with submucosal injection of hyaluronic acid (TS-905 Blue Eye) will be performed.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fauze Maluf Filho, Instituto do Cancer do Estado de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06077981
- Sponsor's protocol ID
- NP3042/22
- Status last verified
- Jul 2026
- First submitted
- 27 Sep 2023
- Last updated
- 17 Jul 2026
- 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 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 0.4% Hyaluronic Acid Solution Versus Hydroxyethylamide Solution in Submucosal Endoscopic Resections of Superficial Malignant Esophageal Neoplasms: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT06077981
- Acronym / sponsor ID
- NP3042/22
- Keywords
- Esophageal Neoplasms, Endoscopic Mucosal Resection, Hyaluronic Acid
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Study start
- 19 Jun 2023 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 11 Oct 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.
This is a randomized, single-center clinical trial that will compare the efficacy of two substances used in the submucosal cushion formation stage of endoscopic submucosal resections of early esophageal malignant neoplasms. Such substances are hyaluronic acid in the form of TS-905 Blue Eyeₒ and hydroxyethylamide (Voluven®).
Detailed description
- Design of the study: This is a randomized clinical trial in a single center. The lesions will be randomized into three blocks based on the diameter of the largest axis (less than 3 cm, between 3 - 5 cm and greater than 5 cm).
- Selection of patients: The population studied will be patients with early esophageal neoplasia diagnosed and/or referred for submucosal endoscopic dissection at the São Paulo Cancer Institute (ICESP), University of São Paulo.
- Evaluation of effectiveness and definitions:
Effectiveness will be measured from the degree of usefulness. The degree of utility will be determined from two variables: obtaining or not a complete block resection and additional number of submucosal injections performed during endoscopic dissection. The solution that results in a complete block resection with a number of additional injections of 0 (excellent utility degree) or 1 (good utility degree) will be considered effective.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomization shall consist of 30 patients, of which: 15 will be from the hydroxyethylamide Group, where the submucosal endoscopic dissection will be performed with submucosal injection of hydroxyethylamide. 15 will be from the Hyaluronic acid group (TS-905 Blue Eye), where the submucosal endoscopic dissection with submucosal injection of hyaluronic acid (TS-905 Blue Eye) will be performed.
| Arm | Type | Receives |
|---|---|---|
| Hydroxyethylamide Group | Active comparator | Procedure: Submucous Endoscopic Dissection with hydroxyethylamide15 will be from the hydroxyethylamide Group, where the submucosal endoscopic dissection will be performed with submucosal injection of hydroxyethylamide. |
| Hyaluronic acid group (TS-905 Blue Eye) | Active comparator | Procedure: Submucous Endoscopic Dissection with Hyaluronic acid (TS-905 Blue Eye)15 will be from the Hyaluronic acid group (TS-905 Blue Eye), where the submucosal endoscopic dissection with submucosal injection of hyaluronic acid (TS-905 Blue Eye) will be performed. |
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 over 18 years of age
- Superficial esophageal adenocarcinoma or squamous cell carcinoma with indication of ESD after discussion in a multidisciplinary oncological board
- Signed informed consent form
Key exclusion criteria (5 listed)
- Residual or recurrent esophageal lesions
- Ulcerated esophageal lesions
- Patients with severe cardiovascular, kidney or liver disease
- History of hypersensitivity to hyaluronic acid
- Pregnant or lactating women
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 |
|---|---|---|
| Submucous Endoscopic Dissection with hydroxyethylamideThe resection will be performed in three stages using hydroxyethylamide : delimitation, incision and dissection. Initially we will inject the hydroxyethylamide and examine the delimitation of the lesion. With Knife itself, using soft or Forced coagulation current, we will circumvent the limits of the lesion with punctual coagulations 5 mm away from it. | Procedure or surgery | Hydroxyethylamide Group |
| Submucous Endoscopic Dissection with Hyaluronic acid (TS-905 Blue Eye)The resection will be performed in three stages using Hyaluronic acid (TS-905 Blue Eye) : delimitation, incision and dissection. Initially we will inject the Blue-Eyed and examine the delimitation of the lesion. With Knife itself, using soft or Forced coagulation current, we will circumvent the limits of the lesion with punctual coagulations 5 mm away from it. | Procedure or surgery | Hyaluronic acid group (TS-905 Blue Eye) |
Primary outcome
Volume of solution
Time frame: During the procedure
Compare the volume of TS-905 Blue Eye versus the solution of hydroxyethylamide used.
2 secondary outcomes
Procedure duration in minutes
Time frame: During the procedure
Number of additional injections
Time frame: During 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 17 Jul 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 Submucous Endoscopic Dissection with hydroxyethylamide and Submucous Endoscopic Dissection with Hyaluronic acid (TS-905 Blue Eye) in people with Esophageal Neoplasms and Endoscopic Mucosal Resection, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
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 5 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 17 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 1 site in Brazil. 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 Fauze Maluf-Filho, PhD (+5511991919014, fauze.maluf@terra.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume of solution (time frame: During the procedure). 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 17 Jul 2026.