Zenker DiverticulumZENKER LSNCT01739426
Evaluation of Endoscopic Treatment of Zenker's Diverticulum Using LigaSure
A study testing Repair w/LigaSure in people with Zenker Diverticulum, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The primary objective of this study is to evaluation the success of endoscopic treatment of Zenker's diverticulum using a LigaSure device (thermal fusion of vessels) via a measure of swallowing function at 12 months post-surgery. 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?
- Repair w/LigaSure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2013to Jun 2015
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient is available for 12 months of follow-up
- The patient has a Zenkers diverticulum as confirmed by a pharyngo-oesophagean transit test, regardless of van Overbeek classification
Who cannot join
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient (or his/her person-of-trust) refuses to sign the consent
- It is impossible to correctly inform the patient
- The patient does not read french
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- The patient is pregnant
- The patient is breastfeeding
- The patients has a contraindication for a treatment necessary for this study, or for general anesthesia
- The patent has a history of complications related to hemostasis
- The preoperative checkup indicates potential for hemostasis related problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Endoscopic Treatment of Zenker's Diverticulum Using the LigaSure Thermal Vessel Sealing System
The primary objective of this study is to evaluation the success of endoscopic treatment of Zenker's diverticulum using a LigaSure device (thermal fusion of vessels) via a measure of swallowing function at 12 months post-surgery.
Read the detailed description
Our secondary objectives are:
- To evaluate short-term (pain, fever, time to start of eating) and medium-term (weight, swallowing) post-operative parameters.
- To evaluate the prevalence of post-operative complications.
- Conditions
- Zenker Diverticulum
- Being tested
- Repair w/LigaSure
- Keywords
- LigaSure V (TM)
- Medical subject headings
- Zenker Diverticulum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repair w/LigaSureDevice
Surgical repair is carried out as normal except that a novel device is used: LigaSure V (TM) laparoscopic instrument (reference LS1500)
| Study group | Role | What they receive |
|---|---|---|
| Study population | Experimental | The population is composed of patients with a confirmed Zenker's diverticulum.
Intervention: Repair w/LigaSure Receives: Device: Repair w/LigaSure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operational success according to the van Overbeek classification (yes/no)
Measured: 12 months
Change in Deglutition Handicap Index score
Measured: baseline to 12 months
Secondary outcomes (16)
Change in Deglutition Handicap Index score
Measured: baseline to Day 3
Change in Deglutition Handicap Index score
Measured: baseline to 6-8 weeks
Change in visual analog scale for pain
Visual analog scale varying from 0 to 10
Measured: baseline to day 1
Change in visual analog scale for pain
Visual analog scale varying from 0 to 10
Measured: baseline to day 2
Change in visual analog scale for pain
Visual analog scale varying from 0 to 10
Measured: baseline to day 3
Change in Temperature (°C)
Measured: baseling to Day 1
Change in Temperature (°C)
Measured: baseling to Day 2
Change in Temperature (°C)
Measured: baseling to Day 3
Time until the patient restarts eating (hours)
Measured: Day 1
Time until the patient restarts eating (hours)
Measured: Day 2
Time until the patient restarts eating (hours)
Measured: Day 3
Change in weight
Change in weight measured in kilograms
Measured: baseline to 6-8 weeks
Change in weight
Change in weight measured in kilograms
Measured: baseline to 12 months
Presence/absence of post-operative complications
Measured: Day 0 (day of surgery)
Presence/absence of post-operative complications
Measured: Day 1
Presence/absence of post-operative complications
Measured: 6-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2012 (estimated)
- Study startMar 2013
- Primary completionJun 2015
- Study completionJun 2015
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.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie Kacha, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01739426
- Sponsor's protocol ID
- LOCAL/2012/SK-02
- Other IDs
- 2012-A01096-37
- Acronym
- ZENKER LS
- Status last verified
- Oct 2015
- First submitted
- 28 Nov 2012
- Last updated
- 22 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Endoscopic Treatment of Zenker's Diverticulum Using the LigaSure Thermal Vessel Sealing System
- ClinicalTrials.gov ID
- NCT01739426
- Acronym / sponsor ID
- ZENKER LS / LOCAL/2012/SK-02
- Conditions
- Zenker Diverticulum
- Keywords
- LigaSure V (TM)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 3 Dec 2012 (estimated)
- 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 primary objective of this study is to evaluation the success of endoscopic treatment of Zenker's diverticulum using a LigaSure device (thermal fusion of vessels) via a measure of swallowing function at 12 months post-surgery.
Detailed description
Our secondary objectives are:
- To evaluate short-term (pain, fever, time to start of eating) and medium-term (weight, swallowing) post-operative parameters.
- To evaluate the prevalence of post-operative complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study population | Experimental | Device: Repair w/LigaSureThe population is composed of patients with a confirmed Zenker's diverticulum. Intervention: Repair w/LigaSure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient is available for 12 months of follow-up
- The patient has a Zenkers diverticulum as confirmed by a pharyngo-oesophagean transit test, regardless of van Overbeek classification
Key exclusion criteria (11 listed)
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient (or his/her person-of-trust) refuses to sign the consent
- It is impossible to correctly inform the patient
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 |
|---|---|---|
| Repair w/LigaSureSurgical repair is carried out as normal except that a novel device is used: LigaSure V (TM) laparoscopic instrument (reference LS1500) | Device | Study population |
Primary outcome
Operational success according to the van Overbeek classification (yes/no)
Time frame: 12 months
Change in Deglutition Handicap Index score
Time frame: baseline to 12 months
16 secondary outcomes
Change in Deglutition Handicap Index score
Time frame: baseline to Day 3
Change in Deglutition Handicap Index score
Time frame: baseline to 6-8 weeks
Change in visual analog scale for pain
Time frame: baseline to day 1
Change in visual analog scale for pain
Time frame: baseline to day 2
Change in visual analog scale for pain
Time frame: baseline to day 3
Change in Temperature (°C)
Time frame: baseling to Day 1
Change in Temperature (°C)
Time frame: baseling to Day 2
Change in Temperature (°C)
Time frame: baseling to Day 3
Time until the patient restarts eating (hours)
Time frame: Day 1
Time until the patient restarts eating (hours)
Time frame: Day 2
Time until the patient restarts eating (hours)
Time frame: Day 3
Change in weight
Time frame: baseline to 6-8 weeks
Change in weight
Time frame: baseline to 12 months
Presence/absence of post-operative complications
Time frame: Day 0 (day of surgery)
Presence/absence of post-operative complications
Time frame: Day 1
Presence/absence of post-operative complications
Time frame: 6-8 weeks
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 22 Oct 2015.
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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.
Sophie Kacha, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repair w/LigaSure in people with Zenker Diverticulum, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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 11 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 22 Oct 2015. 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 France. 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?
Operational success according to the van Overbeek classification (yes/no) (time frame: 12 months). 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 22 Oct 2015.