Heart and Blood Diseases

All Conditions

Nervous System Diseases

Neoplasms

Rare Diseases

Hypertension

Stroke

Intracranial Hypertension

Pseudotumor Cerebri

Hydrocephalus

Hydrocephalus, Normal Pressure

Brain Neoplasms

Hemorrhagic Stroke

Vascular Diseases

Brain Diseases

Central Nervous System Diseases

Cerebrovascular Disorders

Idiopathic Intracranial Hypertension

CODMAN CERTAS Plus Programmable Valve, CODMAN CERTAS Plus Small Inline Programmable Valve, and CODMAN CERTAS Plus Right Angle Programmable Valve.

Patients will undergo implantation of the CODMAN CERTAS Plus Programmable Valve according to the device label.

CODMAN CERTAS Plus Programmable Valve

Maria Salmon-Sargeant

Andrew Tummon

Dimitri Vanhauwaert, MD

Stijn Van Damme, SC

Dr. Oliver Müller

Thomas Beez, MD

Fljamur Aljiji, SC

Dr. Philipp Dammann

Dr. Mukesch Johannes Shah

Dr. Oliver Gandslandt

Sherese Fralin, MSN, FNP, PhD

Post-Market Clinical Follow-up Registry of Patients with CODMAN CERTAS Plus Programmable Valves.

The CODMAN CERTAS Plus Programmable Valve is a single use implantable device designed for shunting cerebrospinal fluid (CSF) for the treatment of hydrocephalus.

The valve can be set to 8 different performance settings for intraventricular pressure and drainage of CSF. The performance setting of the valve can be set preoperatively and can also be noninvasively changed post-implantation.

This clinical investigation will maintain data for each patient from the date of implant through 3 years post-implantation.

Data collection for each patient will occur per standard of care.

However, the clinical investigation specifically aims to collect and analyze data from the day of procedure, and post-operatively at 1 month, 3 months, 6 months, 12 months, 24 months, and 36 months.

Data from follow-up visits will be analyzed according to pre-defined time-intervals referring to these follow-up moments.

Post Market Clinical Follow-up of CODMAN CERTAS Programmable Valve

Post-Market Clinical Follow-up of Patients With CODMAN CERTAS Plus Programmable Valve

Incidence of Valve replacement post - implantation

Incidence of Adverse Events post - implantation

Long term safety will be assessed by the incidence of all adverse events/complications including number of subjects with shunt and/or shunt system infections.

Incidence of inadvertent reprogramming of CODMAN CERTAS Plus Programmable Valves post - implantation prior to MRI

Device Success is defined as:

1. Deployment with the correct valve positioning
2. Original intended device in place, and
3. No additional surgical or interventional procedures related to access or the device since completion of the original procedure.

Integra LifeSciences Corporation

Skin and Connective Tissue Diseases

Behaviors and Mental Disorders

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Eye Diseases

Symptoms and General Pathology

Nutritional and Metabolic Diseases

Breast Neoplasms

Alzheimer Disease

Prostatic Neoplasms

Macular Degeneration

Parkinson Disease

Heart Diseases

Ischemic Stroke

Ischemia

Parkinsonian Disorders

Ganglion Cysts

Synovial Cyst

Basal Ganglia Diseases

Movement Disorders

Synucleinopathies

Neurodegenerative Diseases

Dementia

Tauopathies

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Retinal Degeneration

Retinal Diseases

Familial Alzheimer Disease

Quality of Life

Caregivers randomized in intervention arm will receive an information booklet (which informs about existing structures and actions) and will receive support provided by a social worker schedule every 6 months during two years. The support duration will be one hour and will be defined as two parts: administration of the LASA questionnaire, and a standardized semi directive interview to assess needs.

Support provided by social worker

Caregivers will only receive an information booklet (which informs about existing structures and actions)

Information booklet receipt

Virginie NERICH, Dr

Medical progress and modification of lifestyles have prolonged life expectancy, despite the development of chronic diseases. The support and care are often provided by a network of informal caregivers composed of family, friends, and neighbors. They became essential to help maintening the elderly persons to live at home. It has been demonstrated that the importance and the diversity of informal tasks may jeopardize their own physical, mental and social well-being.

The aim of the Informal Carers of Elderly Cohort is to define, through a longitudinal study of their life course, the profiles of caregivers of patients with a diagnosis of one of the following diseases: cancer (breast, prostate, colon-rectum), neuro-degenerative diseases (Parkinson's disease, Alzheimer's and similar diseases), neuro-vascular diseases (Cerebrovascular Accident (CVA)), Age-related Macular Degeneration(AMD) and heart disease (heart failure), aged ≥ 60 years old and living in Burgundy or Franche-Comte. By following the different phases of the caregiving relationship from the announcement of the diagnosis, it will be possible to assess the quality of life of caregivers and evaluate the implementation of a pragmatic social action to help informal caregivers through a randomized intervention trial nested in the cohort.

Thanks to an analytical and longitudinal definition of the profiles of informal caregivers, this study could gather precise information on their life courses and their health trajectory by identifying the consequences associated with the concept of their role of aid in care. In addition, the randomized intervention trial will explore the efficacy, in terms of quality of life, and efficiency of a social action to support the caregivers. These data will allow to identify strategies that could be used to improve the existing sources of aid and to propose new approaches to help caregivers. This study will provide the opportunity to identify the most relevant means of support and to give an impulse for new healthcare policies.

Multicenter Prospective Cohort of Informal Caregivers in Burgundy and Franche-Comté

Multicenter Prospective Cohort of Informal Caregivers in Burgundy-Franche-Comté. ICE Cohort (Informal Caregivers of Elderly)

The main objective of the randomized study is to compare the Health Related Quality of Life based on summaries score the MOS SF36 one year after randomization according to the allocated intervention.

The main objective of the observational study is to define the longitudinal profiles of patient's caregivers according to the evaluation of their HRQoL using the MOS SF36 questionnaire

the aim of the observational study is to define the longitudinal profiles of cancer patient's caregivers according to the evaluation of their HRQoL using the CarGoQoL questionnaire

The aim of the observational study is to define the longitudinal profiles of patient's caregivers according to the evaluation of their coping strategies using the Borteyrou, Rascle and Truchot Questionnaire.

The aim of the observational study is to define the longitudinal profiles of patient's caregivers according to the evaluation of their anxiety and depression according to the HADs questionnaire.

The aim of the observational study is to define the longitudinal profiles of patient's caregivers according to the evaluation of their social support using the SSQ6 questionnaire.

The aim of the observational study is to define the longitudinal profiles of patient's caregivers according to the evaluation burden using the Zarit burden inventory

To compare the Health Related Quality of Life based on summaries score the MOS SF36 two years after randomization according to the allocated intervention.

To compare longitudinally all dimensions of HRQoL using the MOS SF36 questionnaire according to the allocated intervention.

To compare longitudinally the HRQoL of cancer patients' caregivers, according to the allocated intervention, using the CarGoQol questionnaire.

To compare longitudinally the coping strategies of patients' caregivers, according to the allocated intervention, using the Borteyrou, Rascle and Truchot Questionnaire.

To compare longitudinally the feelings of anxiety and depression of patients' caregivers, according to the allocated intervention, using the HADs Questionnaire.

To compare longitudinally the social support of patients' caregivers, according to the allocated intervention, using the SSQ6 questionnaire.

To compare longitudinally the burden of patients' caregivers, according to the allocated intervention, using the Zarit burden inventory.

The efficiency of the intervention of a social worker for caregivers will be assessed using a cost-utility analysis, aiming at comparing in terms of costs and utility the intervention versus the absence of intervention of a social worker

to evaluate the caregivers/patients' relationship and the changes of the relationship using a qualitative approach (semi-structure interview), to describe the specificity of the care and of the help from people carrying diseases with behavioral disorders (Alzheimer-type dementia in particular)

to study the situations generating a rupture in their role of caregiver (entry into an institution or death, disease remission) using a qualitative approach (semi-structure interview)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Post Market Clinical Follow-up of CODMAN CERTAS Programmable Valve	NCT05397106	Hydrocephalus Hydrocephalus i... NPH (Normal Pre... IIH - Idiopathi... Brain Tumor Post-Traumatic ... Hemorrhagic Str...	CODMAN CERTAS P...	-	Integra LifeSciences Corporation
Post Market Clinical Follow-up of CODMAN CERTAS Programmable Valve	NCT05397106	Hydrocephalus Hydrocephalus i... NPH (Normal Pre... IIH - Idiopathi... Brain Tumor Post-Traumatic ... Hemorrhagic Str...	CODMAN CERTAS P...	-	Integra LifeSciences Corporation
Multicenter Prospective Cohort of Informal Caregivers in Burgundy and Franche-Comté	NCT02626377	Breast Cancer Colorectal Canc... Prostate Cancer Alzheimer Disea... Age-related Mac... Parkinson Disea... Cardiac Disease Ischemic Stroke Hemorrhagic Str...	Support provide... Information boo...	60 Years -	Centre Hospitalier Universitaire de Besancon

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