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Transluminal Flexible Endoscopic Procedure in Foregut and Urologic Surgery

NCT00484783 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2014-12-16

No results posted yet for this study

Summary

NOTES access is safe and feasible in the controlled human setting and comparable to standard-of-care surgical techniques. NOTES exploration of the abdomen provides adequate visualization comparable to laparoscopy.

Conditions

  • Gastric Foreign Body, Nos
  • Disorder of Abdomen (Disorder)
  • Foreign Body in Esophagus
  • Prostatic Diseases
  • Disease of Small Intestine

Interventions

PROCEDURE

Natural Orifice Transluminal Endoscopic Surgery (NOTES)

Patients will have the standard laparoscopic procedure and the NOTES procedure will be added. The surgical procedure will require two operating teams: one led by a laparoscopic surgeon, the other by an endoscopic surgeon. During the usual course of the surgery, the flexible endoscope will be passed through the mouth urethra top gain access to the peritoneal cavity.

PROCEDURE

Natural Orifice Translumenal Endoscopic Surgery (NOTES)

chart review of historical data from control group

Sponsors & Collaborators

  • University Hospitals Cleveland Medical Center

    lead OTHER

Principal Investigators

  • Jeffrey M. Marks, MD · University Hospitals of Cleveland/ Institute for Surgical Innovation

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00484783 on ClinicalTrials.gov