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Evaluation of Endoscopic Treatment of Zenker's Diverticulum Using LigaSure (ZENKER LS)

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ClinicalTrials.gov Identifier: NCT01739426
Recruitment Status : Completed
First Posted : December 3, 2012
Last Update Posted : October 22, 2015
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Brief 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.

Condition or disease Intervention/treatment Phase
Zenker Diverticulum Device: Repair w/LigaSure Not Applicable

Detailed Description:

Our secondary objectives are:

A. To evaluate short-term (pain, fever, time to start of eating) and medium-term (weight, swallowing) post-operative parameters.

B. To evaluate the prevalence of post-operative complications.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Endoscopic Treatment of Zenker's Diverticulum Using the LigaSure Thermal Vessel Sealing System
Study Start Date : March 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Study population

The population is composed of patients with a confirmed Zenker's diverticulum.

Intervention: Repair w/LigaSure

Device: Repair w/LigaSure
Surgical repair is carried out as normal except that a novel device is used: LigaSure V (TM) laparoscopic instrument (reference LS1500)




Primary Outcome Measures :
  1. Operational success according to the van Overbeek classification (yes/no) [ Time Frame: 12 months ]
  2. Change in Deglutition Handicap Index score [ Time Frame: baseline to 12 months ]

Secondary Outcome Measures :
  1. Change in Deglutition Handicap Index score [ Time Frame: baseline to Day 3 ]
  2. Change in Deglutition Handicap Index score [ Time Frame: baseline to 6-8 weeks ]
  3. Change in visual analog scale for pain [ Time Frame: baseline to day 1 ]
    Visual analog scale varying from 0 to 10

  4. Change in visual analog scale for pain [ Time Frame: baseline to day 2 ]
    Visual analog scale varying from 0 to 10

  5. Change in visual analog scale for pain [ Time Frame: baseline to day 3 ]
    Visual analog scale varying from 0 to 10

  6. Change in Temperature (°C) [ Time Frame: baseling to Day 1 ]
  7. Change in Temperature (°C) [ Time Frame: baseling to Day 2 ]
  8. Change in Temperature (°C) [ Time Frame: baseling to Day 3 ]
  9. Time until the patient restarts eating (hours) [ Time Frame: Day 1 ]
  10. Time until the patient restarts eating (hours) [ Time Frame: Day 2 ]
  11. Time until the patient restarts eating (hours) [ Time Frame: Day 3 ]
  12. Change in weight [ Time Frame: baseline to 6-8 weeks ]
    Change in weight measured in kilograms

  13. Change in weight [ Time Frame: baseline to 12 months ]
    Change in weight measured in kilograms

  14. Presence/absence of post-operative complications [ Time Frame: Day 0 (day of surgery) ]
  15. Presence/absence of post-operative complications [ Time Frame: Day 1 ]
  16. Presence/absence of post-operative complications [ Time Frame: 6-8 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01739426


Locations
France
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 9, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Sophie Kacha, MD Centre Hospitalier Universitaire de Nîmes

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01739426     History of Changes
Other Study ID Numbers: LOCAL/2012/SK-02
2012-A01096-37 ( Other Identifier: RCB number )
First Posted: December 3, 2012    Key Record Dates
Last Update Posted: October 22, 2015
Last Verified: October 2015

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
LigaSure V (TM)

Additional relevant MeSH terms:
Diverticulum
Zenker Diverticulum
Pathological Conditions, Anatomical
Diverticulum, Esophageal