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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01739426
Recruitment Status : Completed
First Posted : December 3, 2012
Last Update Posted : October 22, 2015
Sponsor:
Information provided by (Responsible Party):

November 28, 2012
December 3, 2012
October 22, 2015
March 2013
June 2015   (Final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01739426 on ClinicalTrials.gov Archive Site
  • 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 ]
    Visual analog scale varying from 0 to 10
  • Change in visual analog scale for pain [ Time Frame: baseline to day 2 ]
    Visual analog scale varying from 0 to 10
  • Change in visual analog scale for pain [ Time Frame: baseline to day 3 ]
    Visual analog scale varying from 0 to 10
  • 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 measured in kilograms
  • Change in weight [ Time Frame: baseline to 12 months ]
    Change in weight measured in kilograms
  • 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 ]
Same as current
Not Provided
Not Provided
 
Evaluation of Endoscopic Treatment of Zenker's Diverticulum Using LigaSure
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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Zenker Diverticulum
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)
Experimental: Study population

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

Intervention: Repair w/LigaSure

Intervention: Device: Repair w/LigaSure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
June 2015
June 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01739426
LOCAL/2012/SK-02
2012-A01096-37 ( Other Identifier: RCB number )
Yes
Not Provided
Not Provided
Centre Hospitalier Universitaire de Nīmes
Centre Hospitalier Universitaire de Nīmes
Not Provided
Principal Investigator: Sophie Kacha, MD Centre Hospitalier Universitaire de Nîmes
Centre Hospitalier Universitaire de Nīmes
October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP