8 research outputs found
Recommended from our members
Aspiration therapy for the treatment of obesity: 4-year results of a multicenter randomized controlled trial.
BackgroundThe AspireAssist is the first Food and Drug Administration-approved endoluminal device indicated for treatment of class II and III obesity.ObjectivesWe earlier reported 1-year results of the PATHWAY study. Here, we report 4-year outcomes.SettingUnited States-based, 10-center, randomized controlled trial involving 171 participants with the treatment arm receiving Aspiration Therapy (AT) plus Lifestyle Therapy and the control arm receiving Lifestyle Therapy (2:1 randomization).MethodsAT participants were permitted to continue in the study for an additional year up to a maximum of 5 years providing they maintained at least 10% total weight loss (TWL) from baseline at each year end. For AT participants who continued the study, 5 medical monitoring visits were provided at weeks 60, 68, 76, 90, and 104 and thereafter once every 13 weeks up to week 260. Exclusion criteria were a history of eating disorder or evidence of eating disorder on a validated questionnaire. Follow-up weight, quality of life, and co-morbidities were compared with the baseline levels. In addition, rates of serious adverse event, persistent fistula, withdrawal, and A-tube replacement were reported. All analyses were performed using a per-protocol analysis.ResultsOf the 82 AT participants who completed 1 year, 58 continued to this phase of the trial. Mean baseline body mass index of these 58 patients was 41.6 ± 4.5 kg/m2. At the end of first year (at the beginning of the follow-up study), these 58 patients had a body mass index of 34.1 ± 5.4 kg/m2 and had achieved an 18.3 ± 8.0% TWL. On a per protocol basis, patients experienced 14.2%, 15.3%, 16.6%, and 18.7% TWL at 1, 2, 3, and 4 years, respectively (P < .01 for all). Forty of 58 patients (69%) achieved at least 10% TWL at 4 years or at time of study withdrawal. Improvements in quality of life scores and select cardiometabolic parameters were also maintained through 4 years. There were 2 serious adverse events reported in the second through fourth years, both of which resolved with removal or replacement of the A tube. Two persistent fistulas required surgical repair, representing approximately 2% of all tube removals. There were no clinically significant metabolic or electrolytes disorders observed, nor any evidence for development of any eating disorders.ConclusionsThe results of this midterm study have shown that AT is a safe, effective, and durable weight loss alternative for people with class II and III obesity and who are willing to commit to using the therapy and adhere to adjustments in eating behavior
The Lantern Vol. 76, No. 1, Fall 2008
• Cruel • A Night in Three Parts • The Moment I Said It • To Know • I Will Never Skipskipskip a Rock • The Ravine • Untitled • Skeleton • Midnight Letter • Where Children Come From • Orphan of War • Ciega / Mezquita • The Other Side • Those Dancing Days are Gone • Cycling • The 2nd of July • The Tantric Semantics of Studying Abroad • A Three-Part Study in Musical Relations • Amway Man • Hard Luck Investigator • Spring • Interview With Poet Eleanor Wilnerhttps://digitalcommons.ursinus.edu/lantern/1173/thumbnail.jp
The Lantern Vol. 74, No. 2, Spring 2007
• La Viuda • The Curb After Light Drizzling • Loose Cream • The Problem of Ants • Streetplay • Avignon, Anno Domini 1348 • Autophagia • Silverette-New Wave Fascist Date Routine • Mint Shavings • Dogtags • Millenials • Rain That Sleeps by Itself at Track Number 5 • Amorphous • I Found a Flashlight • Sippikkul Muthu: Pearl Within Shell • Of Lies • The Complications of a Fish-Only Diet • Ashes • Unto the Fourth Generation • Marooned on Piano Island • Sweethttps://digitalcommons.ursinus.edu/lantern/1170/thumbnail.jp
The Lantern Vol. 75, No. 1, Fall 2007
• Black Cat • Divorce • The Picture in the Basement • An Ode to the \u2750s Housewife; or Go Go Sylvia Plath • Paradise from a Clock • The Fifth • Moveable Feast • Deathbed • July 17th • Words • Autobiography • The Raving • The Dream Hater • The Moon Rose Late • Tree, the Big, Very Old One in the Middle of Campus • Apple Bit • Sub Atomic Romance • God Came • Extinction • Ski Masks and Knee Caps • Of Silhouettes and Dominoeshttps://digitalcommons.ursinus.edu/lantern/1171/thumbnail.jp
The Lantern Vol. 75, No. 2, Spring 2008
• In a French Courtyard at the Philadelphia Museum of Art • Picky Mangoes • And for My Un-Birthday I Drank Poets\u27 Tea and Got to See • Tree-Baby • Wrestling With Plants • I Smile • Walking Home • The Wall Between • Phalangese, or the Art of Speaking to Fingers • Early Spring • Karma Kids • A Bazaar Triptych • The Joys of Ritual Circumcision • [Of] Archetype[s] or I Don\u27t Like Your Poetry • Truth and Beauty Bombed • Chevalier Anachronistic • Kinds of Birds • Sparknotes Entry for The Changing Tide by Eric Relvas • Thirst • The Devil\u27s Dictionary • Portrait of an Artist Who Loves Icarus • Dinner at the Old House • The Meaning of a Dust-Busterhttps://digitalcommons.ursinus.edu/lantern/1172/thumbnail.jp
The Lantern Vol. 74, No. 1, Fall 2006
• Seven Haikus About Insomnia • Lunch Hour • Divorced Parents and Flower Guts • 24 • Lily • Growth • Narcissistically Admiring You • Mysterious Avocado • Aloha Roast • Summer • Lines • Internalizing • San Francisco • Numb Candle • Moments No. 1 • Tanka • Euphemism • We be Malllllll • Dragon Magic • Time for the Magic Show • Green • Job • The Shire • Venom • The Seasons of Love • The Position • Fragments of an Artist • Peace • Vagabond Nights • Rerum Concordia Discorshttps://digitalcommons.ursinus.edu/lantern/1169/thumbnail.jp
Recommended from our members
Aspiration therapy for the treatment of obesity: 4-year results of a multicenter randomized controlled trial.
BackgroundThe AspireAssist is the first Food and Drug Administration-approved endoluminal device indicated for treatment of class II and III obesity.ObjectivesWe earlier reported 1-year results of the PATHWAY study. Here, we report 4-year outcomes.SettingUnited States-based, 10-center, randomized controlled trial involving 171 participants with the treatment arm receiving Aspiration Therapy (AT) plus Lifestyle Therapy and the control arm receiving Lifestyle Therapy (2:1 randomization).MethodsAT participants were permitted to continue in the study for an additional year up to a maximum of 5 years providing they maintained at least 10% total weight loss (TWL) from baseline at each year end. For AT participants who continued the study, 5 medical monitoring visits were provided at weeks 60, 68, 76, 90, and 104 and thereafter once every 13 weeks up to week 260. Exclusion criteria were a history of eating disorder or evidence of eating disorder on a validated questionnaire. Follow-up weight, quality of life, and co-morbidities were compared with the baseline levels. In addition, rates of serious adverse event, persistent fistula, withdrawal, and A-tube replacement were reported. All analyses were performed using a per-protocol analysis.ResultsOf the 82 AT participants who completed 1 year, 58 continued to this phase of the trial. Mean baseline body mass index of these 58 patients was 41.6 ± 4.5 kg/m2. At the end of first year (at the beginning of the follow-up study), these 58 patients had a body mass index of 34.1 ± 5.4 kg/m2 and had achieved an 18.3 ± 8.0% TWL. On a per protocol basis, patients experienced 14.2%, 15.3%, 16.6%, and 18.7% TWL at 1, 2, 3, and 4 years, respectively (P < .01 for all). Forty of 58 patients (69%) achieved at least 10% TWL at 4 years or at time of study withdrawal. Improvements in quality of life scores and select cardiometabolic parameters were also maintained through 4 years. There were 2 serious adverse events reported in the second through fourth years, both of which resolved with removal or replacement of the A tube. Two persistent fistulas required surgical repair, representing approximately 2% of all tube removals. There were no clinically significant metabolic or electrolytes disorders observed, nor any evidence for development of any eating disorders.ConclusionsThe results of this midterm study have shown that AT is a safe, effective, and durable weight loss alternative for people with class II and III obesity and who are willing to commit to using the therapy and adhere to adjustments in eating behavior