Post-Market Clinical Follow-Up to Access & Visualize the Anus, Rectum, & Distal Colon During Transanal Procedures

NCT ID: NCT03323060

Last Updated: 2019-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-11

Study Completion Date

2019-12-30

Brief Summary

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To assess the safety and performance of the Medrobotics Flex Robotic System and Flex Rectoscope for accessing and visualizing the Anus, Rectum, and Distal Colon when used for Transanal procedures

Detailed Description

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Conditions

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Disease or Lesions of the Anus, Rectum, or Distal Colon

Study Design

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Observational Model Type

FAMILY_BASED

Study Time Perspective

PROSPECTIVE

Study Groups

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Male and/or females ≥ 22 yrs old

≥ 22 years of age requiring transanal procedures in the areas of the anus, rectum, and distal colon Transanal endoscopic surgical procedure

Transanal endoscopic surgical procedure

Intervention Type DEVICE

Resection of tumors or lesions

Interventions

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Transanal endoscopic surgical procedure

Resection of tumors or lesions

Intervention Type DEVICE

Other Intervention Names

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Laparoscopy

Eligibility Criteria

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Inclusion Criteria

* ≥ 22 years of age
* Candidate for transanal procedures in the areas of the anus, rectum, and distal colon.

Exclusion Criteria

* Candidates are excluded if they \< 22 years of age and do not meet criteria for transanal surgery in the anus, rectum, and distal colon
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medrobotics Corporation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Univsersity of Nevada School of Medicine

Las Vegas, Nevada, United States

Site Status

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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FLX-CRC-PMK-US-001

Identifier Type: -

Identifier Source: org_study_id

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