Endoscopic ResectionNCT03050333
Efficacy and Safety of Endoscopic Resection
An observational study of Endoscopic Resection and Gastrointestinal Neoplasms, run by EDUARDO ALBENIZ at 1 site in Spain.
Trial summary
An observational, prospective, multicentre and international study. This will be a non-interventional study to evaluate the efficacy and safety of endoscopic resection of gastrointestinal lesions and to determine what are the factors related to complications, and to describe these lesions according to the different… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endoscopic Resection, Gastrointestinal Neoplasms
- How many people
- 3,000 participants
- Where
- 1 siteSpain
- Study dates
- 25 Apr 2013to 31 Dec 2023
- Phase
- Observational
- 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
Study population: Patients with a clinical indication for endoscopic resection at the different participating centers will be consecutively included in this study.
Who may be able to join
- Female and male patients who are at least 18 years old.
- Clinical indication for endoscopic exam and endoscopic resection
- Patients must freely accept their involvement in this study. They shall give a written informed consent
Who cannot join
- Patients who do not desire to be included in this study
Trial locations and contacts
1 site in 1 country.
EDUARDO ALBENIZ, MD contact
Spain1 site, 1 recruiting
- Recruiting
Eduardo Albeniz Arbizu
Pamplona, Navarre, 31008
EDUARDO ALBENIZ, MD, edualbeniz@hotmail.com
FERRAN CAPDEVILA, PHARMD, fcapdevb@navarra.es
About this study
An observational, prospective, multicentre and international study. This will be a non-interventional study to evaluate the efficacy and safety of endoscopic resection of gastrointestinal lesions and to determine what are the factors related to complications, and to describe these lesions according to the different morphologic and histologic classifications.
- Conditions
- Endoscopic Resection, Gastrointestinal Neoplasms
- Medical subject headings
- Gastrointestinal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of complete resections without recurrence
Measured: 6 month post-endoscopic resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2017
- Study start25 Apr 2013
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endoscopic 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EDUARDO ALBENIZ
- Sponsor type
- University, hospital or other
- Collaborators
- Fundacion Miguel Servet
- Responsible party
- Sponsor-investigator, EDUARDO ALBENIZ, Fundacion Miguel Servet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03050333
- Sponsor's protocol ID
- ALB-RME-2013-01
- Status last verified
- Feb 2017
- First submitted
- 3 Feb 2017
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Albeniz E, Gimeno-Garcia AZ, Fraile M, Ibanez B, Guarner-Argente C, Alonso-Aguirre P, Alvarez MA, Gargallo CJ, Pellise M, Ramos Zabala F, Herreros de Tejada A, Nogales O, Martinez-Ares D, Mugica F, de la Pena J, Espinos J, Huerta A, Alvarez A, Gonzalez-Santiago JM, Navajas F, Martinez-Cara JG, Redondo-Cerezo E, Merlo Mas J, Sabado F, Rivero L, Saperas E, Soto S, Rodriguez-Sanchez J, Lopez-Roses L, Rodriguez-Tellez M, Rullan Iriarte M, Elosua Gonzalez A, Pardeiro R, Valdivielso Cortazar E, Concepcion-Martin M, Huelin Alvarez P, Colan Hernandez J, Cobian J, Santiago J, Jimenez A, Remedios D, Lopez-Viedma B, Garcia O, Martinez-Alcala F, Perez-Roldan F, Carbo J, Enguita M. Clinical validation of risk scoring systems to predict risk of delayed bleeding after EMR of large colorectal lesions. Gastrointest Endosc. 2020 Apr;91(4):868-878.e3. doi: 10.1016/j.gie.2019.10.013. Epub 2019 Oct 23.
PubMed 31655045
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Endoscopic Resection
- ClinicalTrials.gov ID
- NCT03050333
- Acronym / sponsor ID
- ALB-RME-2013-01
- Conditions
- Endoscopic Resection, Gastrointestinal Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- EDUARDO ALBENIZUniversity, hospital or other
- Collaborators
- Fundacion Miguel Servet
- Study start
- 25 Apr 2013 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 10 Feb 2017 (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.
An observational, prospective, multicentre and international study. This will be a non-interventional study to evaluate the efficacy and safety of endoscopic resection of gastrointestinal lesions and to determine what are the factors related to complications, and to describe these lesions according to the different morphologic and histologic classifications.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a clinical indication for endoscopic resection at the different participating centers will be consecutively included in this study.
Key inclusion criteria (3 listed)
- Female and male patients who are at least 18 years old.
- Clinical indication for endoscopic exam and endoscopic resection
- Patients must freely accept their involvement in this study. They shall give a written informed consent
Key exclusion criteria (1 listed)
- Patients who do not desire to be included in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of complete resections without recurrence
Time frame: 6 month post-endoscopic resection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
- Derived from this study: PubMed 31655045Albeniz E, Gimeno-Garcia AZ, Fraile M, Ibanez B, Guarner-Argente C, Alonso-Aguirre P, Alvarez MA, Gargallo CJ, Pellise M, Ramos Zabala F, Herreros de Tejada A, Nogales O, Martinez-Ares D, Mugica F, de la Pena J, Espinos J, Huerta A, Alvarez A, Gonzalez-Santiago JM, Navajas F, Martinez-Cara JG, Redondo-Cerezo E, Merlo Mas J, Sabado F, Rivero L, Saperas E, Soto S, Rodriguez-Sanchez J, Lopez-Roses L, Rodriguez-Tellez M, Rullan Iriarte M, Elosua Gonzalez A, Pardeiro R, Valdivielso Cortazar E, Concepcion-Martin M, Huelin Alvarez P, Colan Hernandez J, Cobian J, Santiago J, Jimenez A, Remedios D, Lopez-Viedma B, Garcia O, Martinez-Alcala F, Perez-Roldan F, Carbo J, Enguita M. Clinical validation of risk scoring systems to predict risk of delayed bleeding after EMR of large colorectal lesions. Gastrointest Endosc. 2020 Apr;91(4):868-878.e3. doi: 10.1016/j.gie.2019.10.013. Epub 2019 Oct 23.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
EDUARDO ALBENIZ, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endoscopic Resection and Gastrointestinal Neoplasms, run by EDUARDO ALBENIZ 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 10 Feb 2017. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact EDUARDO ALBENIZ, MD (edualbeniz@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of complete resections without recurrence (time frame: 6 month post-endoscopic resection). 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 NCT03050333, which also lists 1 linked publication.
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 10 Feb 2017.