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Gastrointestinal CancerNCT06588881

Endoscopic Nebulizing Device for Surgical Haemostatic-sealant Glubran® 2 Usability Trial in EMR and ESD

A study testing nebulized application of the haemostatic surgical sealant after gastrointestinal endoscopic resection in people with Gastrointestinal Cancer, run by GEM SRL at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this single-center study is to evaluate the feasibility of the technique, usability and safety of the device ENDONEB. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Gastrointestinal Cancer
What is being tested?
nebulized application of the haemostatic surgical sealant after gastrointestinal endoscopic resection
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteItaly
Study dates
14 Mar 2023to 28 Mar 2024
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Clinical diagnosis of superficial neoplastic lesion to be resected by a gastrointestinal endoscopic resection (EMR or ESD)
  • Older than 18 years of age at time of consent;
  • Operable per institution's standards;
  • Signed and dated informed consent form

Who cannot join

  • Any clinical conditions precluding the feasibility of gastrointestinal endoscopic resection (ENDONEB could be contraindicated in patients who are suspected of having a gastrointestinal perforation, or are at high risk of gastrointestinal perforation during endoscopic treatment);
  • Pregnant during period of study participation;
  • Allergy history to cyanoacrylate.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, Italy

Other trials in Italy

About this study

Official title: A Pilot Study on Feasibility of Technique, Performance and Safety of ENDONEB Endoscopic Medical Device for the Nebulized Application of the Haemostatic Surgical Sealant After Gastrointestinal Endoscopic Resection

The aim of this single-center study is to evaluate the feasibility of the technique, usability and safety of the device ENDONEB.

Read the detailed description

Single center, prospective, medical device usability and feasibility study. The study will be performed in Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome.

According to the recomandations of the Italian Ministry of Health (28) regarding the sample size of pilot and feasibility studies, 15 applications underwent to mucosal or submucosal resection procedures will be evaluated. The recruitment period will be 36 weeks (9 months). The evaluation ends when ENDONEB has been used in the fifteenth subject or at one third of applications if the investigators will be able to give their evaluation of the feasibility of the ENDONEB technique, usability and safety. The ENDONEB medical device belongs to the family of "Nebulizers" class IIa accessory devices, used to apply Glubran®2 in nebulized form in laparotomic, laparoscopic and thoracoscopic procedures. The ENDONEB medical device allows to apply the Glubran®2 in nebulized form in digestive endoscopy interventions and can be used both with gastroscopes and colonoscopes with an operating channel not less than 2.6 mm. It is marketed in sterile presentation; the components are latex free and is for single use only.

Being tested
nebulized application of the haemostatic surgical sealant after gastrointestinal endoscopic resection
Medical subject headings
Gastrointestinal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • nebulized application of the haemostatic surgical sealant after gastrointestinal endoscopic resectionDevice

    ENDONEB, a nebulizing catheter containing the synthetic haemostatic-sealant Glubran®, is inserted in the operative channel of the endoscope until it is pushed out of the endoscope tip approximately 2 cm. The haemostatic-sealant is nebulized over the surface of the post resection mucosal defect by activating the propellant (medical-inert-gas) container. An amount of about 0.3 mL of Glubran® 2 (or more - depending on dimension of the lesion) is applied on mucosal or sub-mucosal defect in order to create a proper haemostaticsealant film.

Study groups in NCT06588881
Study groupRoleWhat they receive
ENDONEBOtherThe sterile device and gamma rays, latex free and disposable consists of the following components: a steel canister, a catheter 2m hose, one attack base located at the proximal end of the catheter, one unit at the end back, two needles and two syringes. The device must always be stored in the original packaging. Store only in one place Temp temperature not exceeding 30°C(86°)Application procedure: The device must be pr repaired and activated adequately in order to ensure its correctness operation. See instructions for assembly and indoor use of the package.
Receives: Device: nebulized application of the haemostatic surgical sealant after gastrointestinal endoscopic resection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate the feasibility of the technique

    Appropriateness of ENDONEB medical nebulizer device to apply the surgical haemostatic-sealant Glubran® 2 after gastrointestinal endoscopic resections evaluated in terms of positioning correctly the ENDONEB device for procedure as per the user manual\'s instructions. The outcome is measured with score 1-5 corresponding to the quality assessment: 1=not sufficient; 2=sufficient; 3=good; 4=very good; 5=excellent.

    Measured: From the beginning of the surgery until the end of surgery. Approximately 3 hours.

  2. Evaluate the feasibility of the technique

    Appropriateness of ENDONEB medical nebulizer device to apply the surgical haemostatic-sealant Glubran® 2 after gastrointestinal endoscopic resections evaluated in terms of facility of use and satisfaction/effectiveness of the surgeon. The outcome is mesaured with score 1-5 corresponding to the quality assessment: 1=not sufficient; 2=sufficient; 3=good; 4=very good; 5=excellent.

    Measured: From the beginning of the surgery until the end of surgery. Approximately 3 hours.

Secondary outcomes (8)

  1. Evaluate the ENDONEB Usability and Safety

    Performance: evaluation of the device under anticipated conditions of use will be get by testing (verifying) the following issues:

    • the facility to assembly the device (setting up time, easiness in assembly, single operator assembly). Each point is mesaured with score 1-5 corresponding to the quality assessment: 1=not sufficient; 2=sufficient; 3=good; 4=very good; 5=excellent.

    Measured: From the beginning of the surgery until the end of surgery. Approximately 3 hours.

  2. Evaluate the ENDONEB Usability and Safety

    Performance: evaluation of the device under anticipated conditions of use will be get by testing (verifying) the following issues:

    • the ability to deliver the haemostatic-sealant to the resection site. The outcome is mesaured with score 1-5 corresponding to the quality assessment: 1=not sufficient; 2=sufficient; 3=good; 4=very good; 5=excellent.

    Measured: From the beginning of the surgery until the end of surgery. Approximately 3 hours.

  3. Evaluate the ENDONEB Usability and Safety

    Performance: evaluation of the device under anticipated conditions of use will be get by testing (verifying) the following issues:

    • the ability to use the device through the endoscope. The outcome is mesaured with score 1-5 corresponding to the quality assessment: 1=not sufficient; 2=sufficient; 3=good; 4=very good; 5=excellent.

    Measured: From the beginning of the surgery until the end of surgery. Approximately 3 hours.

  4. Evaluate the ENDONEB Usability and Safety

    Performance: evaluation of the device under anticipated conditions of use will be get by testing (verifying) the following issues:

    • the duration of the procedure to use the device (time). The outcome is mesaured in minutes.

    Measured: From the beginning of the surgery until the end of surgery. Approximately 3 hours.

  5. Evaluate the ENDONEB Usability and Safety

    Performance: evaluation of the device under anticipated conditions of use will be get by testing (verifying) the following issues:

    • ease of use in terms of capacity to control and manage the device. The outcome is mesaured with score 1-5 corresponding to the quality assessment: 1=not sufficient; 2=sufficient; 3=good; 4=very good; 5=excellent.

    Measured: From the beginning of the surgery until the end of surgery. Approximately 3 hours.

  6. Evaluate the ENDONEB Usability and Safety

    Performance: evaluation of the device under anticipated conditions of use will be get by testing (verifying) the following issues:

    • any technical complications during the procedure of application. The evaluation of this outcome is a detailed description of the technical complications that occurred.

    Measured: From the beginning of the surgery until the end of surgery. Approximately 3 hours.

  7. Evaluate the ENDONEB Usability and Safety

    Safety assessment will be performed by verifying any episodes of device malfunction during the entire application such as:

    • failure or breakage of the device. The measure of this outcome is reported with a detailed description of the event.

    Measured: From the beginning of the surgery until the end of surgery. Approximately 3 hours.

  8. Evaluate the ENDONEB Usability and Safety

    Safety assessment will be performed by verifying any episodes of device malfunction during the entire application such as:

    • lengthening of application times due to obstruction of the catheter or obstruction of the operating channel. The outcome is measured with a score from 1 to 5 corresponding to the quality assessment: 1=not sufficient; 2=sufficient; 3=good; 4=very good; 5=excellent.

    Measured: From the beginning of the surgery until the end of surgery. Approximately 3 hours.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start14 Mar 2023
  3. Primary completion28 Mar 2024
  4. Study completion28 Mar 2024

Resources

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
Other
Allocation
Not applicable
Intervention model
Sequential
Model description
Single center, prospective, medical device usability and feasibility study.
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06588881
Sponsor's protocol ID
DGDMF/I.5.i.m.2/2022/2045
Status last verified
Sep 2024
First submitted
7 Aug 2024
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing nebulized application of the haemostatic surgical sealant after gastrointestinal endoscopic resection in people with Gastrointestinal Cancer, run by GEM SRL at 1 site in Italy.

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 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 19 Sep 2024. 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 Italy. 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?

Evaluate the feasibility of the technique (time frame: From the beginning of the surgery until the end of surgery. Approximately 3 hours.). 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?

On the ClinicalTrials.gov record for NCT06588881.

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 19 Sep 2024.

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