Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00484783
Status:
COMPLETED
Last Update Posted:
2014-12-16
First Post:
2007-06-07
Brief Title:
Transluminal Flexible Endoscopic Procedure in Foregut and Urologic Surgery
Sponsor:
University Hospitals Cleveland Medical Center
Organization:
University Hospitals Cleveland Medical Center
Study Overview
Official Title:
Prospective Evaluation of the Intraoperative Use of Translumenal Flexible Endoscopes During Combined Flexible and Laparoscopic Foregut and Urologic Surgery
Status:
COMPLETED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NOTES
Brief 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
Detailed Description:
This is a prospective clinical trial to evaluate the feasibility of obtaining peritoneal cavity access from natural orifice translumenal endoscopic surgery NOTES during combined laparoscopic-endoscopic foregut surgery Post-operative course will be compared with a historical chart-review control group of patients undergoing standard laparoscopic foregut and urologic surgery
The study group will be compiled by open enrollment for male and female adult subjects scheduled for combined laparoscopic-endoscopic surgery of the stomach abdominal esophagus prostate bladder proximal small intestine or who meet inclusion and exclusion criteria The historical chart-review control group will be randomly chosen from patients from 2003-2006 having undergone combined laparoscopic-endoscopic surgery of the foregut prostate or bladder and as determined by CPT coding
The purpose of the study is to determine if NOTES access and abdominal exploration is feasible safe offers comparable visualization to laparoscopy in a controlled human setting
The study group will be compiled by open enrollment for male and female adult subjects scheduled for combined laparoscopic-endoscopic surgery of the stomach abdominal esophagus prostate bladder proximal small intestine or who meet inclusion and exclusion criteria The historical chart-review control group will be randomly chosen from patients from 2003-2006 having undergone combined laparoscopic-endoscopic surgery of the foregut prostate or bladder and as determined by CPT coding
The purpose of the study is to determine if NOTES access and abdominal exploration is feasible safe offers comparable visualization to laparoscopy in a controlled human setting
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None