Evaluation of Endoscopic Treatment of Zenker's Diverticulum Using LigaSure

Zenker Diverticulum Clinical Trial

— ZENKER LS  

Official title:

Evaluation of Endoscopic Treatment of Zenker's Diverticulum Using the LigaSure Thermal Vessel Sealing System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01739426
• Other study ID #: LOCAL/2012/SK-02
• Secondary ID: 2012-A01096-37
• Status: Completed
• Phase: N/A
• First received: November 28, 2012
• Last updated: October 21, 2015
• Start date: March 2013
• Est. completion date: June 2015

Study information

• Verified date: October 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diverticulum
• Zenker Diverticulum

Intervention

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)

Locations

Country	Name	City	State
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 9

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operational success according to the van Overbeek classification (yes/no)		12 months	Yes
Primary	Change in Deglutition Handicap Index score		baseline to 12 months	Yes
Secondary	Change in Deglutition Handicap Index score		baseline to Day 3	Yes
Secondary	Change in Deglutition Handicap Index score		baseline to 6-8 weeks	Yes
Secondary	Change in visual analog scale for pain	Visual analog scale varying from 0 to 10	baseline to day 1	Yes
Secondary	Change in visual analog scale for pain	Visual analog scale varying from 0 to 10	baseline to day 2	Yes
Secondary	Change in visual analog scale for pain	Visual analog scale varying from 0 to 10	baseline to day 3	Yes
Secondary	Change in Temperature (°C)		baseling to Day 1	Yes
Secondary	Change in Temperature (°C)		baseling to Day 2	Yes
Secondary	Change in Temperature (°C)		baseling to Day 3	Yes
Secondary	Time until the patient restarts eating (hours)		Day 1	Yes
Secondary	Time until the patient restarts eating (hours)		Day 2	Yes
Secondary	Time until the patient restarts eating (hours)		Day 3	Yes
Secondary	Change in weight	Change in weight measured in kilograms	baseline to 6-8 weeks	Yes
Secondary	Change in weight	Change in weight measured in kilograms	baseline to 12 months	Yes
Secondary	Presence/absence of post-operative complications		Day 0 (day of surgery)	Yes
Secondary	Presence/absence of post-operative complications		Day 1	Yes
Secondary	Presence/absence of post-operative complications		6-8 weeks	Yes