Zenker DiverticulumNCT03948438
Endoscopic Treatment for Zenker's Diverticulum
An observational study of Zenker Diverticulum, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
Zenker's diverticulum (ZD) is a rare benign condition, due to an acquired sac-like outpouching of the mucosa and submucosa layers originating from the pharyngoesophageal junction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Zenker Diverticulum
- What is being tested?
- Endoscopic septotomy
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2009to 30 Dec 2028
- Phase
- Observational
- 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
Study population: patients affected by ZD and treated by endoscopic procedures.
Who may be able to join
- patients with symptomatic ZD treated by endoscopic procedures
Who cannot join
- pregnancy and breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alessandro Repici, Prof. contact
Italy1 site, 1 recruiting
- Recruiting
Humanitas Research Hospital
Rozzano, 20089
Alesandro Repici, MD, 0039-02-82247493, alessandro.repici@hunimed.eu
Milena Di Leo, MD
About this study
Official title: Clinical Outcome of Endoscopic Treatment for Zenker's Diverticulum
Zenker's diverticulum (ZD) is a rare benign condition, due to an acquired sac-like outpouching of the mucosa and submucosa layers originating from the pharyngoesophageal junction. Endoscopic techniques like flexible endoscopic septum division (FESD) or per-oral endoscopic septotomy (POES), represent a minimally invasive alternative to surgery or to rigid endoscopic procedure to treat ZD. The goal of the research will be to evaluate the safety of the procedures and to measure Zenker-symptom severity in all patients treated by endoscopic procedures.
- Conditions
- Zenker Diverticulum
- Being tested
- Endoscopic septotomy
- Medical subject headings
- Zenker Diverticulum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic septotomyProcedure or surgery
Patients will be placed in left lateral decubitus position, either in conscious sedation or under deep sedation with propofol or endotracheal intubation.The procedure will be performed with a flexible standard endoscope and started with initial endoscopic examination with suction of possible retained material insidethe diverticulum. An incision of the bridge between the ZD and the esophagus will be done (using one endoscopic procedure as POES or FESD or other)
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events
Any complications as bleeding, perforation, others
Measured: 24 hours after the procedure
Secondary outcomes (1)
symptoms after the procedure
The frequency of symptoms such as dysphagia, regurgitation, weight loss
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start1 Jan 2009
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (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 Zenker DiverticulumStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03948438
- Sponsor's protocol ID
- ICH Zenker
- Status last verified
- Sep 2022
- First submitted
- 8 May 2019
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Repici A, Cappello A, Spadaccini M, Nicoletti R, Carrara S, Fugazza A, Galtieri PA, Lamonaca L, Romana C, Badalamenti M, Di Leo M, Pellegatta G, Ferrara EC, Anderloni A, Maselli R. Cap-Assisted Endoscopic Septotomy of Zenker's Diverticulum: Early and Long-Term Outcomes. Am J Gastroenterol. 2021 Sep 1;116(9):1853-1858. doi: 10.14309/ajg.0000000000001356.
PubMed 34236338
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome of Endoscopic Treatment for Zenker's Diverticulum
- ClinicalTrials.gov ID
- NCT03948438
- Acronym / sponsor ID
- ICH Zenker
- Conditions
- Zenker Diverticulum
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 14 May 2019 (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.
Zenker's diverticulum (ZD) is a rare benign condition, due to an acquired sac-like outpouching of the mucosa and submucosa layers originating from the pharyngoesophageal junction. Endoscopic techniques like flexible endoscopic septum division (FESD) or per-oral endoscopic septotomy (POES), represent a minimally invasive alternative to surgery or to rigid endoscopic procedure to treat ZD. The goal of the research will be to evaluate the safety of the procedures and to measure Zenker-symptom severity in all patients treated by endoscopic procedures.
Study design
- Observational model
- Cohort
- 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 affected by ZD and treated by endoscopic procedures.
Key inclusion criteria (1 listed)
- patients with symptomatic ZD treated by endoscopic procedures
Key exclusion criteria (1 listed)
- pregnancy and breastfeeding
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 |
|---|---|---|
| Endoscopic septotomyPatients will be placed in left lateral decubitus position, either in conscious sedation or under deep sedation with propofol or endotracheal intubation.The procedure will be performed with a flexible standard endoscope and started with initial endoscopic examination with suction of possible retained material insidethe diverticulum. An incision of the bridge between the ZD and the esophagus will be done (using one endoscopic procedure as POES or FESD or other) | Procedure or surgery | – |
Primary outcome
Incidence of Adverse Events
Time frame: 24 hours after the procedure
Any complications as bleeding, perforation, others
1 secondary outcome
symptoms after the procedure
Time frame: up to 5 years
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 21 Sep 2022.
- Derived from this study: PubMed 34236338Repici A, Cappello A, Spadaccini M, Nicoletti R, Carrara S, Fugazza A, Galtieri PA, Lamonaca L, Romana C, Badalamenti M, Di Leo M, Pellegatta G, Ferrara EC, Anderloni A, Maselli R. Cap-Assisted Endoscopic Septotomy of Zenker's Diverticulum: Early and Long-Term Outcomes. Am J Gastroenterol. 2021 Sep 1;116(9):1853-1858. doi: 10.14309/ajg.0000000000001356.
- Individual participant dataSharing planned: No
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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.
Alessandro Repici, Prof. 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 Zenker Diverticulum, run by Istituto Clinico Humanitas 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 1 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: looking for participants now, as of the sponsor's last update on 21 Sep 2022. 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?
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 Alessandro Repici, Prof. (alessandro.repici@hunimed.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (time frame: 24 hours after the procedure). 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 NCT03948438, 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 21 Sep 2022.