International Hernia Mesh Registry (IHMR)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00622583 |
Recruitment Status
:
Recruiting
First Posted
: February 25, 2008
Last Update Posted
: January 3, 2018
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Sponsor:
Ethicon, Inc.
Information provided by (Responsible Party):
Ethicon, Inc.
Tracking Information | |||||
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First Submitted Date | February 14, 2008 | ||||
First Posted Date | February 25, 2008 | ||||
Last Update Posted Date | January 3, 2018 | ||||
Actual Study Start Date | September 1, 2007 | ||||
Estimated Primary Completion Date | December 1, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures |
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Change History | Complete list of historical versions of study NCT00622583 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures |
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Current Other Outcome Measures | Not Provided | ||||
Original Other Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | International Hernia Mesh Registry | ||||
Official Title | A Two-Year Follow-up, Post-Implantation, Multi-center, International Hernia Mesh Registry | ||||
Brief Summary | To determine patient reported long-term outcomes, and post-implantation clinical characteristics related to the use of mesh products in 3,500 patients minimum. | ||||
Detailed Description | To help identify best practices leading to lower recurrence rates and decreases in chronic pain associated with the hernia repair procedure. | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Other Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | Primary care clinic and patients of the investigators at local clinics or hospitals. | ||||
Condition | Hernia | ||||
Intervention | Not Provided | ||||
Study Groups/Cohorts | Observation Group
Subjects who meet the inclusion/exclusion criteria who have had a hernia repair. |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
3500 | ||||
Original Estimated Enrollment |
3000 | ||||
Estimated Study Completion Date | December 1, 2021 | ||||
Estimated Primary Completion Date | December 1, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts |
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Listed Location Countries | Australia, Belgium, Canada, China, France, Germany, Italy, Netherlands, South Africa, Spain, Sweden, United Kingdom, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT00622583 | ||||
Other Study ID Numbers | 200-06-007 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement | Not Provided | ||||
Responsible Party | Ethicon, Inc. | ||||
Study Sponsor | Ethicon, Inc. | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | Ethicon, Inc. | ||||
Verification Date | January 2018 |