Study of the NDO Endoscopic Plication System For the Treatment of Symptomatic Gastroesophageal Reflux Disease

NACompletedINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

August 31, 2001

Primary Completion Date

May 31, 2003

Study Completion Date

May 31, 2003

Conditions
GERD
Interventions
DEVICE

NDO Full-thickness Plicator

The Plicator and gastroscope assembly were passed into the stomach. The stomach was distended with air. The gastroscope was advanced and retroflexed so that the instrument could be visualized and accurately positioned. The Plicator was retroflexed to within 1cm below the GE junction, and the helical tissue retractor was advanced deeply into the gastric wall. The gastric wall was retracted into the Plicator instrument arms. The arms were then closed, and the suture-implant was deployed to secure the full-thickness plication. The tissue retractor is then disengaged and the suture-implant released from the instrument.

Trial Locations (7)

29425

Medical University of South Carolina, Charleston

55905

Mayo Clinic, Rochester

90048

Cedars Sinai Medical Center, Los Angeles

98101

Virginia Mason Medical Center, Seattle

02115

Beth Israel Deaconess Medical Center, Boston

03756

Dartmouth Hitchcock Medical Center, Lebanon

M4X1W4

St. Michael's Hospital, Toronto

All Listed Sponsors
lead

NDO Surgical, Inc.

INDUSTRY

NCT00587522 - Study of the NDO Endoscopic Plication System For the Treatment of Symptomatic Gastroesophageal Reflux Disease | Biotech Hunter | Biotech Hunter