NCT04899726

Description of the Safety and Functionality of a Rectoscope (P201630551)

Description of the Safety and Functionality of a Rectoscope (P201630551) That Allows the Identification of the Distal Section Margin in Oncological Rectal Surgery

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Instituto de Investigación Hospital Universitario La Paz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Most patients with rectal cancer receive neoadjuvant therapy. This usually causes a decrease in tumor size. In approximately 20% of patients who receive neoadjuvant therapy, the tumor disappears completely (complete pathological response), showing as a scar on the rectal mucosa, not noticeable from the rectal serosa, from outside the rectum, difficulting the identification of the tumor location by the surgeon. Rectoscope (p201630551) allows the surgeon to view the illuminated rectum from the patient's abdomen, determining the appropriate point of section of the rectum.

Conditions

• Oncological Rectal Surgery

Interventions

Type	Name	Description
DEVICE	Rectoscope (P201630551)	Rectoscope (P201630551) allows the identification of the distal section margin in oncological rectal surgery.

Timeline

• Start date: 2020-07-14
• Primary completion: 2022-08-01
• Completion: 2022-09-01
• First posted: 2021-05-24
• Last updated: 2021-05-26

Locations

1 site across 1 country: Spain