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

Medrobotics

Status: Unknown

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

Treatments: Device: Transanal endoscopic surgical procedure

Study type: Observational

Funder types: Other

Identifiers

NCT03323060

FLX-CRC-PMK-US-001

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 1 patient group

Male and/or females ≥ 22 yrs old

Description:

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

Treatment:

Device: Transanal endoscopic surgical procedure