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The purpose of this study is to demonstrate that the Covidien EEA™ Hemorrhoid and Prolapse Stapling Set for the treatment of hemorrhoids is non-inferior to the competitor device based on the primary endpoint.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EEA Hemorrhoid and Prolapse Stapling Set | Experimental |
| |
| Endosurgery Proximate PPH03 Stapling Set | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EEA Hemorrhoid and Prolapse Stapling Set | Device | Surgical device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative Bleeding | Number of subjects who require intervention to stop intraoperative bleeding The analysis is based on the per protocol analysis set. Subjects who were misrandomized for excluded from this analysis therefore, the population here will differ from the participant flow. | Day 0 - time of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Post Operative Pain - (PI-NIRS) | Post-operative pain as change from baseline pain score as measured by an 11-point Pain Intensity Numeric Rating Scale (PI-NRS). The range of the scale is 0-10 with 0 representing no pain and 10 representing the worst possible pain. The data represented is the change in baseline score at the different timepoints. | Day 0 minus 60 (baseline), Day 0 (discharge), Day 0 plus 7, Day 0 plus 30, Day 0 plus 90, Day 0 plus 180 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jorge Marcet, MD | University of South Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USF Tampa General Hospital Dept of Surgery | Tampa | Florida | 33606 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | EEA Hemorrhoid and Prolapse Stapling Set | EEA Hemorrhoid and Prolapse Stapling Set : Surgical device |
| FG001 | Endosurgery Proximate PPH03 Stapling Set | Endosurgery Proximate PPH03 Stapling Set : Surgical device |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | EEA Hemorrhoid and Prolapse Stapling Set | EEA Hemorrhoid and Prolapse Stapling Set: Surgical device |
| BG001 | Endosurgery Proximate PPH03 Stapling Set | Endosurgery Proximate PPH03 Stapling Set: Surgical device |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Intraoperative Bleeding | Number of subjects who require intervention to stop intraoperative bleeding The analysis is based on the per protocol analysis set. Subjects who were misrandomized for excluded from this analysis therefore, the population here will differ from the participant flow. | Posted | Number | participants | Day 0 - time of surgery |
|
Two years - January 2011 to Jan 2013
HEEA N=81 is the total population that was intended to be randomized to the study device using the intent to treat modality. The per protocol population once the misrandomized subjects were excluded is N=78
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EEA Hemorrhoid and Prolapse Stapling Set | EEA Hemorrhoid and Prolapse Stapling Set: Surgical device |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Faecoloma | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anorectal Discomfort | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tam LaFleur, Clinical Project Manager | Covidien | 203-821-4744 | tam.lafleur@covidien.com |
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| ID | Term |
|---|---|
| D006484 | Hemorrhoids |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Endosurgery Proximate PPH03 Stapling Set | Device | Surgical device |
|
| Post-Operative Pain (Analgesic Intake) | post operative pain measured in pos-surgical consumption of strong opioids by the number of participants in the study. Participants are included if they consumed analgesics or strong opiod at anytime during the study. | Day 0, 1 week, 2 week, 1 month, 3 month, 6 month |
| Overall Quality of Life - General Health Score | Quality of life was measured by SF-12 questionnaire in change from baseline; the socring range is 0 - 100 with 0 = poor overall health and 100 = excellent overall health | Day 0 minus 60, 1 week, 1 month, 3 months, 6 months |
| Location of the Staple Line | Distance of staple line to dentate line as measure by surgical ruler | Day 0 |
| Length of Stay | Length of hospital stay is defined as time of anoscope insertion until discharge | Day 0 time of discharge minus time of admission |
| Operative Room (OR) Time | Time of insertion of anoscope to time of anoscope removal after stapleline evaluation | Day 0 |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Hemorrhoid Grade | Hemorrhoid grading is based on the scale from The American Society of Colon and Rectal Surgeons classification where grade IV represents the worst onset of hemorrhoids and grade I is the best case. Surgeons use the following classification to grade subjects in the study. Grades increase in severity with Grade I being better than Grade IV Grade Physical Findings I Prominent hemorrhoidal vessels, no prolapse II Prolapse with Valsalva and spontaneous reduction III Prolapse with Valsalva requires manual reduction IV Chronically prolapsed manual reduction ineffective | Number | participants |
|
| Smoking History | Number | participants |
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| Prior Hemorrhoid Treatment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
| Weight | Mean | Standard Deviation | Kg |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Post Operative Pain - (PI-NIRS) | Post-operative pain as change from baseline pain score as measured by an 11-point Pain Intensity Numeric Rating Scale (PI-NRS). The range of the scale is 0-10 with 0 representing no pain and 10 representing the worst possible pain. The data represented is the change in baseline score at the different timepoints. | Posted | Mean | Standard Deviation | units on a scale | Day 0 minus 60 (baseline), Day 0 (discharge), Day 0 plus 7, Day 0 plus 30, Day 0 plus 90, Day 0 plus 180 |
|
|
|
| Secondary | Post-Operative Pain (Analgesic Intake) | post operative pain measured in pos-surgical consumption of strong opioids by the number of participants in the study. Participants are included if they consumed analgesics or strong opiod at anytime during the study. | Posted | Number | participants | Day 0, 1 week, 2 week, 1 month, 3 month, 6 month |
|
|
|
| Secondary | Overall Quality of Life - General Health Score | Quality of life was measured by SF-12 questionnaire in change from baseline; the socring range is 0 - 100 with 0 = poor overall health and 100 = excellent overall health | Posted | Mean | Standard Deviation | units on a scale | Day 0 minus 60, 1 week, 1 month, 3 months, 6 months |
|
|
|
| Secondary | Location of the Staple Line | Distance of staple line to dentate line as measure by surgical ruler | Posted | Mean | Standard Deviation | mm | Day 0 |
|
|
|
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| Secondary | Length of Stay | Length of hospital stay is defined as time of anoscope insertion until discharge | Posted | Mean | Standard Deviation | Hours | Day 0 time of discharge minus time of admission |
|
|
|
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| Secondary | Operative Room (OR) Time | Time of insertion of anoscope to time of anoscope removal after stapleline evaluation | Posted | Mean | Standard Deviation | minutes | Day 0 |
|
|
|
|
| 2 |
| 81 |
| 65 |
| 81 |
| EG001 | Endosurgery Proximate PPH03 Stapling Set | Endosurgery Proximate PPH03 Stapling Set: Surgical device | 3 | 68 | 40 | 68 |
| Proctalgia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Tooth Abscess | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
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| Procedural Pain | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
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| Urinary Retention | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Haematochezia | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Proctalgia | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Operative Hemorrhage | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
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| Suture Insertion | Surgical and medical procedures | MedDRA 13.1 | Non-systematic Assessment |
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| Hemorrhage | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Rectal Hemorrhage | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| (Day 0 plus 7) Week 1 |
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| (Day 0 plus 30) Month 1 |
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| (Day 0 plus 90) Month 3 |
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| (Day 0 plus 180) Month 6 |
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| 1 week - 2 week post op |
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| 2 week - 1 month post op |
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| 1 month - 3 month post op |
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| 3 month - 6 month post op |
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| 1 month |
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| 3 month |
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| 6 month |
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