Safety and Efficacy Study of Pain Shield Device to Treat Subjects Following Laparoscopic-Assisted Abdominal Surgery
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Shaare Zedek Medical Center.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Shaare Zedek Medical Center
Collaborator:
Nanovibronix
Information provided by:
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT00737425
First received: August 17, 2008
Last updated: October 27, 2008
Last verified: October 2008
| Tracking Information | |||||||||
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| First Received Date ICMJE | August 17, 2008 | ||||||||
| Last Updated Date | October 27, 2008 | ||||||||
| Start Date ICMJE | September 2008 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
Pain and discomfort will be measured using appropriate validated questionnaires. [ Time Frame: Pain assessment will be performed daily ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00737425 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Infections will be assessed by concomitant antibiotic intake [ Time Frame: Concomitant medications will be assessed daily ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Safety and Efficacy Study of Pain Shield Device to Treat Subjects Following Laparoscopic-Assisted Abdominal Surgery | ||||||||
| Official Title ICMJE | Evaluation of Safety and Efficacy of the PainShield Device for the Treatment of Subjects Who Underwent Laparoscopic-Assisted Abdominal Surgery | ||||||||
| Brief Summary | The purpose of this study is to evaluate safety and efficacy of PainShield device, based on ultrasound technology, for postoperative pain relief and wound healing following a laparoscopic-assisted abdominal surgery. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
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| Condition ICMJE | Wounds | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* 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 ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 80 | ||||||||
| Completion Date | Not Provided | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Israel | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00737425 | ||||||||
| Other Study ID Numbers ICMJE | NV-PS-02-001 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Prof Petachia Reissman, Head of Surgery Department, Shaare Zedek Medical Center, Jerusalem, Israel | ||||||||
| Study Sponsor ICMJE | Shaare Zedek Medical Center | ||||||||
| Collaborators ICMJE | Nanovibronix | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | Shaare Zedek Medical Center | ||||||||
| Verification Date | October 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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