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The SymCHro - Observational Registry Study for Symbotex™ Composite Mesh in Ventral Hernia Repair (SymCHro)

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ClinicalTrials.gov Identifier: NCT02206828
Recruitment Status : Completed
First Posted : August 1, 2014
Last Update Posted : November 1, 2017
Sponsor:
Information provided by (Responsible Party):
Medtronic - MITG

Brief Summary:
The aim of this Observational Registry Study is to assess the short- and long-term clinicaloutcomes following the use of Symbotex™ Composite Mesh in primary and incisional abdominal wall hernia surgeries by open or laparoscopic approach, according to the Instruction for use (IFU).

Condition or disease
Primary and Incisional Abdominal Wall Hernia Surgeries Using Symbotex™ Composite Mesh by Open or Laparoscopic Approach

Detailed Description:

This is an observational multicenter registry Study. One hundred consecutive, adult patients scheduled for primary and incisional abdominalwall hernia surgeries using Symbotex™ Composite Mesh will be reported in the ClubHernie online database, with standard data captured of all preoperative, perioperative andpost-operative data, for patient's outcomes measurements.

Primary Objective:

Evaluate the incidence of peri-operative and post-operative complications, with postoperativeevaluations occurring, at discharge , 1 week (D1 and D8 follow up), 1 month(D30 follow up), 1Year and 2 Year follow up after primary and incisional abdominal wallhernia surgeries using Symbotex™ Composite Mesh by open or laparoscopic approach(such as anticipated device related complications such as pain, recurrence, complicationsrelated to adhesions, wound complications, other postoperative complications, SAE…).

This online database consists of a systematic and consecutive data entry of all patientstreated for Inguinal Hernia and Ventral Hernia by the 30 French surgeon members, withstandard data captured of all preoperative, perioperative and post-operative data.

The database is required to be completed anonymously. Quality data control of all data captured into the online database will be performed by coherence analysis by Club Hernie authorized representative;A statistical analysis plan will be developed by Covidien.

Study reported device-related events will be reviewed periodically to assess for any potential trends


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Study Type : Observational [Patient Registry]
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Observational Registry Study for Symbotex™ Composite Mesh in Ventral Hernia Repair
Actual Study Start Date : June 25, 2014
Actual Primary Completion Date : May 22, 2017
Actual Study Completion Date : May 22, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Group/Cohort
1 GROUP
Only 1 group not predetermined



Primary Outcome Measures :
  1. Evaluate the incidence of peri-operative and post-operative complications, with postoperative evaluations occurring [ Time Frame: 2 Year follow up ]
    post-operative complications, with postoperative evaluations occurring at 2 Year follow up after primary and incisional abdominal wall hernia surgeries using Symbotex™ Composite Mesh by open or laparoscopic approach(such as anticipated device related complications such as pain, recurrence, complications related to adhesions, wound complications, other postoperative complications, SAE…).


Secondary Outcome Measures :
  1. Description and assessment of the use of Symbotex™ Composite Mesh , surgeon's satisfaction, Quality of life and patient satisfaction...). [ Time Frame: 2 Year follow up ]
    Description and assessment of the use of Symbotex™ Composite Mesh for primary and incisional abdominal wall hernia surgeries (surgical techniques, description of dissection,mesh handling, ease of use, surgeon's satisfaction, Quality of life and patient satisfaction...).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
adult patients scheduled for primary and incisional abdominal wall hernia surgeries
Criteria

Inclusion Criteria:

  • The first one hundred consecutive adult patients scheduled for primary and incisional abdominal wall hernia surgery by Club Hernie members surgeons using Symbotex™Composite Mesh ;- All patients regardless of gender ≥ 18 years of age presenting with ventral hernias.
  • Patients will be informed by surgeon with a written information notice of the nature of the observational registry study.

Exclusion Criteria:

  • No exclusion criteria outside the product IFU

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): NCT02206828


Locations
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France
Club Hernie association represented by Dr Gillion, in his capacity as President
Montrouge, France, 92120
Sponsors and Collaborators
Medtronic - MITG

Additional Information:

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Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT02206828     History of Changes
Other Study ID Numbers: COVSYMB0441
First Posted: August 1, 2014    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: October 2017
Keywords provided by Medtronic - MITG:
HERNIA
SYMCHRO
SOFRADIM
REGISTRY
SYMBOTEX
Additional relevant MeSH terms:
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Hernia
Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal