Zenker DiverticulumNCT04660214
Minimally Invasive Endoscopic Treatment of Zenker's Diverticulum Comparing LigaSureTM vs SB-Knife.
A study testing septotomy in people with Zenker Diverticulum and Minimally Invasive Surgical Procedures, run by Hospital del Rio Hortega at 1 site in Spain.
Trial summary
The main purpose of this trial is to evaluate two devices used in the treatment of Zenker Diverticulum using flexible endoscopy (LigaSure and SB-knife). Analyze the technical success, clinical success, relapses, complications, and the mean procedure time with each device prospectively in order to transfer objective… Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Zenker Diverticulum, Minimally Invasive Surgical Procedures, Endoscopy
- What is being tested?
- septotomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteSpain
- Study dates
- 28 Jun 2021to 31 May 2026
- 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 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with endoscopically confirmed Zenker's diverticulum and presenting symptoms related to it.
- Those who complete the symptom and quality of life questionnaires.
- They must sign informed consent.
Who cannot join
- Previous treatment of Zenker's Diverticulum
- Those for whom Zenker's diverticulum is ruled out at endoscopy.
- Chewing disorders and/or dysphagia secondary to neurological pathology and Oesophageal motility disorders
- Those who do not want to participate in the study and/or who do not sign the informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
The main purpose of this trial is to evaluate two devices used in the treatment of Zenker Diverticulum using flexible endoscopy (LigaSure and SB-knife). Analyze the technical success, clinical success, relapses, complications, and the mean procedure time with each device prospectively in order to transfer objective and uniform results to routine clinical practice.
Read the detailed description
Patients who meet the inclusion criteria will be randomized on the day of the procedure using a computer system that generates a table of random numbers, to perform endoscopic diverticulotomy using a LigaSure device (LS 1500, Covidien; Medtronic, Minneapolis, MN, USA) or with Stag Beetle (SB) knife standard (Sumitomo Bakelite Co. Tokyo, Japan).
Prophylactic intravenous antibiotic therapy is administered prior to the procedure and will be performed under deep sedation with control by an endoscopist or anesthesiologist in the cases indicated.
Gastroscopy will be performed to identify Zenker's diverticulum, and isolate the septum under endoscopic control using a diverticuloscope or flexible overtube (ZD overtube, ZDO 22/30 Cook Medical), after placing a guide (0.035 ", 450 cm Jagwire, Boston Scientific, Natick MA, USA) in the esophageal lumen. The overtube has two leaflets at one of its ends, a longer one that is placed in the esophageal lumen and the short leaflet is placed in the diverticulum. In those cases in which it is not possible to place the diverticuloscope, the septum will be isolated with the help of a cap on the end of the endoscope. In these cases, the device used will always be the SB-Knife since it is not possible to use the LigaSure and they will be excluded from the study analysis.
The time of the procedure will be counted from when the overtube is placed until it is removed after diverticulotomy.
- Being tested
- 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.
septotomyDevice
endoscopic diverticulotomy
| Study group | Role | What they receive |
|---|---|---|
| Vessel sealing device | Active comparator | Endoscopic diverticulectomy is performed with the LigaSure (TM) device Receives: Device: septotomy |
| Dissecting Knife device | Active comparator | Endoscopic diverticulectomy is performed with the SB-Knife(TM) device Receives: Device: septotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the technical success of endoscopic diverticulotomy with SB-Knife and LigaSure
Technical success: achieving septotomy of the mucosa and transverse muscle fibers of the diverticulum septum.
Measured: At the moment of the procedure
Evaluate clinical success of endoscopic diverticulotomy with SB-Knife and LigaSure
Clinical success: disappearance of symptoms or their improvement one month after treatment, evaluated using the Eating-Assessment Tool-10 (>=3 pathological) and Dakkak and Bennett scales (0: asymthomatic; 4 aphagia)
Measured: One month after the procedure
Secondary outcomes (3)
Analyze the mean procedure time with each of the two endoscopic techniques
The procedure time will be counted from the overtube is placed until it is removed after diverticulectomy
Measured: At the end of the recruitment
Analyze immediate and delayed complications with SB-Knife and LigaSure
Complications during the procedure and post-procedure the first 14 days after the procedure):
- bleeding (decrease in Hb with hypotension and / or tachycardia and need for a gastroscope and hospital admission) (endoscopically controlled or if surgical treatment is required)
- perforation: endoscopic control or surgical treatment
- odynophagia or neck pain (VAS Scale)
- Any complication that requires prolonging the hospital stay.
Late complications (from the 15th day and during the first month):
- Haemorrhage that requires endoscopic / surgical treatment or hospital admission for its control
- Oesophageal perforation (conservative or surgical treatment): cervical emphysema, air in the mediastinum.
- Pain that requires hospital admission
Measured: one month after the procedure
Determine the recurrence rates and the mean time to recurrence for each of the techniques
Recurrence: reappearance of symptoms (dysphagia, cough ...) after their disappearance or worsening, reflected in an increase in the scores of the Dakkak and Bennett scales (score ≥1 or increase of 1 point) and EAT -10 (EAT-10 score ≥3 or 3-point increase from previous score).
Measured: at least three months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start28 Jun 2021
- Primary completion5 May 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital del Rio Hortega
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mª Henar Núñez Rodriguez, MD PhD, Hospital del Rio Hortega
- Investigators
- Mª Henar Núñez-Rodriguez, MD PhD, Principal investigator, Gastroenterology Department, Hospital Rio Hortega
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04660214
- Sponsor's protocol ID
- PI208-20
- Status last verified
- Jun 2026
- First submitted
- 24 Nov 2020
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Endoscopic Treatment of Zenker's Diverticulum Comparing LigaSureTM vs SB-Knife.
- ClinicalTrials.gov ID
- NCT04660214
- Acronym / sponsor ID
- PI208-20
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Hospital del Rio HortegaUniversity, hospital or other
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 5 May 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 9 Dec 2020 (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.
The main purpose of this trial is to evaluate two devices used in the treatment of Zenker Diverticulum using flexible endoscopy (LigaSure and SB-knife). Analyze the technical success, clinical success, relapses, complications, and the mean procedure time with each device prospectively in order to transfer objective and uniform results to routine clinical practice.
Detailed description
Patients who meet the inclusion criteria will be randomized on the day of the procedure using a computer system that generates a table of random numbers, to perform endoscopic diverticulotomy using a LigaSure device (LS 1500, Covidien; Medtronic, Minneapolis, MN, USA) or with Stag Beetle (SB) knife standard (Sumitomo Bakelite Co. Tokyo, Japan).
Prophylactic intravenous antibiotic therapy is administered prior to the procedure and will be performed under deep sedation with control by an endoscopist or anesthesiologist in the cases indicated.
Gastroscopy will be performed to identify Zenker's diverticulum, and isolate the septum under endoscopic control using a diverticuloscope or flexible overtube (ZD overtube, ZDO 22/30 Cook Medical), after placing a guide (0.035 ", 450 cm Jagwire, Boston Scientific, Natick MA, USA) in the esophageal lumen. The overtube has two leaflets at one of its ends, a longer one that is placed in the esophageal lumen and the short leaflet is placed in the diverticulum. In those cases in which it is not possible to place the diverticuloscope, the septum will be isolated with the help of a cap on the end of the endoscope. In these cases, the device used will always be the SB-Knife since it is not possible to use the LigaSure and they will be excluded from the study analysis.
The time of the procedure will be counted from when the overtube is placed until it is removed after diverticulotomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vessel sealing device | Active comparator | Device: septotomyEndoscopic diverticulectomy is performed with the LigaSure (TM) device |
| Dissecting Knife device | Active comparator | Device: septotomyEndoscopic diverticulectomy is performed with the SB-Knife(TM) device |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with endoscopically confirmed Zenker's diverticulum and presenting symptoms related to it.
- Those who complete the symptom and quality of life questionnaires.
- They must sign informed consent.
Key exclusion criteria (4 listed)
- Previous treatment of Zenker's Diverticulum
- Those for whom Zenker's diverticulum is ruled out at endoscopy.
- Chewing disorders and/or dysphagia secondary to neurological pathology and Oesophageal motility disorders
- Those who do not want to participate in the study and/or who do not sign the informed consent.
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 |
|---|---|---|
| septotomyendoscopic diverticulotomy | Device | Dissecting Knife device, Vessel sealing device |
Primary outcome
Evaluate the technical success of endoscopic diverticulotomy with SB-Knife and LigaSure
Time frame: At the moment of the procedure
Technical success: achieving septotomy of the mucosa and transverse muscle fibers of the diverticulum septum.
Evaluate clinical success of endoscopic diverticulotomy with SB-Knife and LigaSure
Time frame: One month after the procedure
Clinical success: disappearance of symptoms or their improvement one month after treatment, evaluated using the Eating-Assessment Tool-10 (>=3 pathological) and Dakkak and Bennett scales (0: asymthomatic; 4 aphagia)
3 secondary outcomes
Analyze the mean procedure time with each of the two endoscopic techniques
Time frame: At the end of the recruitment
Analyze immediate and delayed complications with SB-Knife and LigaSure
Time frame: one month after the procedure
Determine the recurrence rates and the mean time to recurrence for each of the techniques
Time frame: at least three months after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- 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. This study is not recruiting at the moment.
Mª Henar Núñez-Rodriguez, MD PhD principal investigator
Gastroenterology Department, Hospital Rio Hortega
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing septotomy in people with Zenker Diverticulum and Minimally Invasive Surgical Procedures, run by Hospital del Rio Hortega 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 4 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 4 Jun 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 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?
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 technical success of endoscopic diverticulotomy with SB-Knife and LigaSure (time frame: At the moment of the procedure). 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?
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 4 Jun 2026.