MILEPOST Multicenter Randomized Controlled Trial: 12-Month Weight Loss and Satiety Outcomes After pose SM vs. Medical Therapy
Abstract
Background Pose SM is an endolumenal weight-loss intervention in which suture anchors are placed endoscopically in the gastric fundus/distal gastric body. Observational studies of pose have shown safe, effective weight loss. Twelve-month results of a randomized controlled trial comparing weight loss and satiety after pose vs. conventional medical therapy are reported.Methods Subjects with classes I-II obesity were randomized in a 3:1 ratio to pose or diet/exercise guidance only (control). Pose subjects received gastric fundus and distal body suture-anchor plications with diet/exercise counseling. Total body (%TBWL) and excess weight loss (%EWL) were assessed at 6 and 12 months. Analysis of covariance (ANCOVA) was used to analyze 12-month %TBWL. Satiety changes were assessed at 6 and 12 months.Results From November 2013 to July 2014, 44 subjects were randomized (34, 77.3 % female; mean age, 38.3 ± 10.7 years; body mass index, 36.5 ± 3.4 kg/m 2) to pose (n = 34) or control (n = 10) groups in three centers. Mean pose procedure time was 51.8 ± 14.5 min; pose subjects received a mean 8.8 ± 1.3 fundal and 4.2 ± 0.7 distal body plications. Twelve-month TBWL: pose, 13.0 % (EWL, 45.0 %), n = 30 vs. control group, 5.3 % (18.1 %), n = 9; significant mean difference, 7.7 % (95 % CI 2.2, 13.2; p < 0.01). Pose subjects showed significant reductions in satiety parameters (p < 0.001); controls experienced reduced caloric intake and satiety volume (p < 0.05). No serious device- or procedure-related adverse events occurred.Conclusions In a randomized controlled trial at 12 months, pose-treated subjects had significantly greater weight loss than those treated with diet/exercise guidance alone. At 6 and 12 months, pose subjects showed significant reduction in satiety parameters.Study registration clinicaltrials.gov identifier # NCT01843231.
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Two RCTs and 1 cohort study investigating the Pose® procedure reported excess weight loss between 16% and 45%.
“Two RCTs and 1 cohort study investigated the effect of the Pose® procedure and reported EWL between 16–45% [149–151].”
From Clinical practice guidelines of the European Association for Endoscopic Surgery (EAES) on bariatric surgery: update 2020 endorsed by IFSO-EC, EASO and ESPCOP (2020) · cites this paper as [149]
The safety profile of the Pose® procedure seems acceptable, but certainty in the evidence was very low.
“The procedure safety profile seems acceptable, however certainty in the evidence was very low.”
From Clinical practice guidelines of the European Association for Endoscopic Surgery (EAES) on bariatric surgery: update 2020 endorsed by IFSO-EC, EASO and ESPCOP (2020) · cites this paper as [149]
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- Authors
- Miller, K., Turró, R., Greve, J. W., Bakker, C. M., Buchwald, J. N., & Espinós, J. C.
- Affiliations
- Hospital Quirón Teknon (ES)
- Zuyderland Medisch Centrum (NL)
- Corresponding author
- Miller, Karl
- ORCID
- Miller, Karl
- Venue
- Obesity Surgery
- Published
- 2016-07-28
- Volume
- 27
- Issue
- 2
- Pages
- 310-322
- ISSN
- 0960-8923 (ISSN-L)
- 1708-0428
- OpenAlex
- W2476724090
- Cited by
- 102
- References
- 38
- Citations by year
- 2026: 2 · 2025: 9 · 2024: 16 · 2023: 8 · 2022: 9 · 2021: 7 · 2020: 14 · 2019: 16 · 2018: 10 · 2017: 9 · 2016: 2
- FWCI
- 13.68
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Obesity Surgery (publishedVersion)
- PubMed (publishedVersion)
- Funders
- USGI Medical-only for manuscript development
- Topics
- Health Sciences › Medicine › Surgery › Bariatric Surgery and Outcomes
- Health Sciences › Medicine › Surgery › Minimally Invasive Surgical Techniques
- Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
- MeSH terms
- Adult, Behavior Therapy, Combined Modality Therapy, Counseling, Diet, Reducing, Endoscopy, Exercise Therapy, Female, Follow-Up Studies, Humans, Male, Middle Aged, Obesity, Morbid, Satiation, Weight Loss, Treatment Outcome, Bariatric Surgery, Young Adult, Weight Reduction Programs
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