A Precision and Accuracy Study of the Codman Valve Position Verification (VPV) System.

NCT00196196 | Completed Phase 3 Results

• 1 other identifier: VPV-US03-001
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of this study is to determine the agreement rate between the CODMAN Valve Position Verification (VPV) adjustment outcome (reprogramming) and X-ray verification in order to support an alternative to X-ray confirmation with respect to the valve adjustment process.

Conditions

Hydrocephalus; Normal Pressure Hydrocephalus

Keywords

Hydrocephalus; Codman Hakim Programmable Valve; Programmable Valve; Shunt System

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieved "Adjustment Complete" and a Consensus X-ray Reading

  Up to 5 attempts to achieve "Adjustment Complete" using the Codman Valve Position Verification (VPV) system for each Subject. Agreement in 2 of 3 valve X-ray readings by independent radiologists for each Subject was considered "consensus X-ray". All participants included achieved "Adjustment Complete" and a "consensus X-ray reading".

  Day 1

Secondary Outcomes (1)

• Percentage of Agreement Between the Codman Valve Position Verification (VPV) System and Consensus X-rays Using Various Thresholds

  Day 1

Interventions

Codman VPV System DEVICE

Valve Positioning Verification (VPV) System

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• A CODMAN Hakim Programmable Valve (CHPV) has been implanted for the management of the Subject's Hydrocephalus.
• The Subject has given written informed consent prior to enrolling in the study.
• The Subject requires adjustment of the CODMAN Hakim Programmable Valve (CHPV) for the management of Hydrocephalus·
• The Subject's implanted CHPV will be adjusted using the Implanted Valve Mode.

You may not qualify if:

• The Subject's valve is located in the deep lumbar position.
• The Subject has an open and/or recent wound site in the region of the implanted valve.
• The Subject has a history of Ultrasound gel allergies.
• The Subject is a prisoner.
• The subject has been previously enrolled in this protocol.

Sponsors & Collaborators

• Codman & Shurtleff: lead

Study Sites (8)

Unknown Facility

Phoenix, Arizona, United States

Location

Unknown Facility

Orlando, Florida, United States

Location

Unknown Facility

Boston, Massachusetts, 02115, United States

Location

Unknown Facility

Newark, New Jersey, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Cleveland, Ohio, United States

Location

Unknown Facility

Portland, Oregon, United States

Location

Unknown Facility

Richardson, Texas, United States

Location

Related Publications (6)

• Bret P, Guyotat J, Ricci AC, Mottolese C, Jouanneau E. [Clinical experience with the Sp[hy adjustable valve in the treatment of adult hydrocephalus. A series of 147 cases]. Neurochirurgie. 1999 May;45(2):98-108; discussion 108-9. French.

  PMID: 10448649 BACKGROUND

• Petrie A, Sabin C. Medical Statistics at a Glance. Blackwell Science Ltd: 90-91

  BACKGROUND

• American Society of Radiologic Technologists, Statement on IOM Report, "To Err Is Human: Building a Safer Health System", www.asrt.org/other_categories/government_relations/iom_report.htm

  BACKGROUND

• Pollack IF, Albright AL, Adelson PD. A randomized, controlled study of a programmable shunt valve versus a conventional valve for patients with hydrocephalus. Hakim-Medos Investigator Group. Neurosurgery. 1999 Dec;45(6):1399-408; discussion 1408-11. doi: 10.1097/00006123-199912000-00026.

  PMID: 10598708 BACKGROUND

• Rohde V, Mayfrank L, Ramakers VT, Gilsbach JM. Four-year experience with the routine use of the programmable Hakim valve in the management of children with hydrocephalus. Acta Neurochir (Wien). 1998;140(11):1127-34. doi: 10.1007/s007010050226.

  PMID: 9870057 BACKGROUND

• Zemack G, Romner B. Seven years of clinical experience with the programmable Codman Hakim valve: a retrospective study of 583 patients. J Neurosurg. 2000 Jun;92(6):941-8. doi: 10.3171/jns.2000.92.6.0941.

  PMID: 10839253 BACKGROUND

MeSH Terms

Conditions

Hydrocephalus; Hydrocephalus, Normal Pressure

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Jandira Ramos, MPH
• Organization: Codman & Shurtleff, Inc.

jramos8@its.jnj.com

508-828-3127

Study Officials

• J. Thomas Megerian, MD

  Codman & Shurtleff

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: September 1, 2004
• Primary Completion: October 1, 2006
• Study Completion: October 1, 2006
• Last Updated: May 28, 2012
• Results First Posted: December 5, 2008

Record last verified: 2011-02

Locations

US (8)