Evaluation of Endoscopic Treatment of Zenker's Diverticulum Using LigaSure

NCT01739426 | Completed DMC

• 2 other identifiers: LOCAL/2012/SK-022012-A01096-37
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Zenker Diverticulum

Keywords

LigaSure V (TM)

Outcome Measures

Primary Outcomes (2)

• Operational success according to the van Overbeek classification (yes/no)

  12 months

• Change in Deglutition Handicap Index score

  baseline to 12 months

Secondary Outcomes (16)

• Change in Deglutition Handicap Index score

  baseline to Day 3

• Change in Deglutition Handicap Index score

  baseline to 6-8 weeks

• Change in visual analog scale for pain

  baseline to day 1

• Change in visual analog scale for pain

  baseline to day 2

• Change in visual analog scale for pain

  baseline to day 3

Study Arms (1)

Study population

EXPERIMENTAL

The population is composed of patients with a confirmed Zenker's diverticulum. Intervention: Repair w/LigaSure

Device: Repair w/LigaSure

Interventions

Repair w/LigaSure DEVICE

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

Study population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• The patient is participating in another 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Zenker Diverticulum

Condition Hierarchy (Ancestors)

Diverticulum, Esophageal; Diverticulum; Diverticular Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Sophie Kacha, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2012
• First Posted: December 3, 2012
• Study Start: March 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: October 22, 2015

Record last verified: 2015-10

Locations

FR (1)