Satiety — the feeling of fullness and disappearance of appetite after a meal — is exactly what Satiety (Palo Alto, California) wants to help patients achieve with its transoral gastroplasty (TOGa) procedure. The comopany presented the first clinical results of its TOGa procedure — a transoral restrictive operation for obesity — at the American College of Gastroenterology meeting in Las Vegas.
Using a plastic tube resembling a miniature hose and an endoscope to watch what is going on, doctors vacuumed the sides of the trial patients' stomachs and applied two 4 cm staple lines to make the stomach smaller, Tom Gibson, Satiety spokesman, told Biomedical Business & Technology.
The TOGa procedure is designed to be less invasive, require less recovery time and have reduced complications compared to existing surgical options, Satiety said.
Though the company is quick to tout the safety and feasibility data from the pilot trial, Jacques Deviere, MD, PhD, chairman of the Department of Gastroenterology, Erasme University Hospital (Brussels, Belgium), the study author, emphasized that the procedure is still in the early trial stage and has only been done in 21 patients worldwide. However, he said he was impressed by the recovery time of the patients in the trial.
"This is true that we observed the recovery time for the patient is significantly shorter, there weren't any abdominal incisions and in an obese patient abdominal incisions can be accommodated with significant complications," Deviere told BB&T in a phone interview from Belgium. "Even in the setting of a pilot trial the day after the procedure the patients were almost all ready to go back home and even one day later go back to work."
In the 21 patients who participated in the trial, Deviere said there were no significant complications other than some mild post-operative pain. He said the most difficult part of the procedure is creating the staple lines.
After one month, patients in the trial lost between nine and 28 pounds, representing 7% to 25% of their weight. Six patients were seen three months after their procedure and had lost between 14% and 29% of their weight. Satiety says it expects to get the TOGa procedure approved in Europe in 2008 and in the U.S. in 2010.