Assessment of a Slotted Anoscope That Facilitates Hemorrhoidectomy

This study has been terminated.

(Slow Enrollment)

Sponsor:

Information provided by (Responsible Party):

Ethicon Endo-Surgery

ClinicalTrials.gov Identifier:

NCT01264835

First received: December 17, 2010

Last updated: February 1, 2012

Last verified: February 2012

History of Changes

Results First Received: November 28, 2011

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Excisional Hemorrhoidectomy
Intervention:	Device: Slotted Anoscope

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Slotted Anoscope	Subjects consenting to have hemorrhoidectomy with the slotted anoscope

Participant Flow: Overall Study

	Slotted Anoscope
STARTED	2
COMPLETED	1
NOT COMPLETED	1
Lost to Follow-up	1

Baseline Characteristics

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Reporting Groups

	Description
Slotted Anoscope	Subjects consenting to have hemorrhoidectomy with the slotted anoscope

Baseline Measures

	Slotted Anoscope
Number of Participants [units: participants]	2
Age [units: participants]
<=18 years	0
Between 18 and 65 years	2
>=65 years	0
Gender [units: participants]
Female	1
Male	1
Region of Enrollment [units: participants]
United States	2

Outcome Measures

1. Primary:

Procedure Duration (Surgery Time) [ Time Frame: Time of surgery ]

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Serious Adverse Events

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Time Frame	No text entered.
Additional Description	No text entered.

Reporting Groups

	Description
Slotted Anoscope	Subjects consenting to have hemorrhoidectomy with the slotted anoscope

Serious Adverse Events

	Slotted Anoscope
Total, serious adverse events
# participants affected / at risk	1/2 (50.00%)
Gastrointestinal disorders
Rectal Ulceration ^{† 1}
# participants affected / at risk	1/2 (50.00%)
# events	1

†	Events were collected by systematic assessment
1	Term from vocabulary, No coding dictionary

Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.

Results Point of Contact:

Name/Title: Michael Schwiers, Principal Biostatistician
Organization: Ethicon Endo-Surgery
phone: 513-337-1172
e-mail: mschwier@its.jnj.com

No publications provided

Responsible Party:	Ethicon Endo-Surgery
ClinicalTrials.gov Identifier:	NCT01264835 History of Changes
Other Study ID Numbers:	CI-10-0003
Study First Received:	December 17, 2010
Results First Received:	November 28, 2011
Last Updated:	February 1, 2012
Health Authority:	United States: Institutional Review Board

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