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Slow Enrollment
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This trial is designed to assess intra-operative procedure outcomes (e.g.,procedure duration) and post-operative patient outcomes (e.g., pain)following a modified Ferguson hemorrhoidectomy procedure using the Slotted Anoscope with Harmonic or monopolar energy.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Slotted Anoscope | Device | SA411 |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure Duration (Surgery Time) | Procedure duration was defined as the length of time in minutes from first insertion of the slotted anoscope to final removal of the slotted anoscope. | Time of surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Alabama | Mobile | Alabama | 36693 | United States | ||
| Saint Joseph's Hospital of Atlanta |
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| ID | Title | Description |
|---|---|---|
| FG000 | Slotted Anoscope | Subjects consenting to have hemorrhoidectomy with the slotted anoscope |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Slotted Anoscope | Subjects consenting to have hemorrhoidectomy with the slotted anoscope |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Procedure Duration (Surgery Time) | Procedure duration was defined as the length of time in minutes from first insertion of the slotted anoscope to final removal of the slotted anoscope. | No analyses are being reported for this outcome measure as this trial was terminated early. The procedure was only performed with the slotted anoscope in 1 subject. No assessment or analysis of primary or secondary objectives was performed. | Posted | Mean | Standard Deviation | minutes | Time of surgery |
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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 | Slotted Anoscope | Subjects consenting to have hemorrhoidectomy with the slotted anoscope |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rectal Ulceration | Gastrointestinal disorders | No coding dictionary | Systematic Assessment |
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No analyses are being reported for the primary outcome measure as this trial was terminated early. The procedure was only performed with the slotted anoscope in 1 subject. No assessment or analysis of primary or secondary objectives was performed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Schwiers, Principal Biostatistician | Ethicon Endo-Surgery | 513-337-1172 | mschwier@its.jnj.com |
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| Atlanta |
| Georgia |
| 30342 |
| United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
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| 1 |
| 2 |
| 0 |
| 2 |
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