Ignite Creation Date:
2024-05-06 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05711758
Status:
RECRUITING
Last Update Posted:
2023-12-19
First Post:
2022-12-29
Brief Title:
Efficacy and Safety of Endoscopic Antral Myotomy as a Novel Weight Loss Procedure
Sponsor:
Christopher C Thompson MD MSc
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Efficacy and Safety of Endoscopic Antral Myotomy as a Novel Weight Loss Procedure A Pilot Study
Status:
RECRUITING
Status Verified Date:
2023-12
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:
PSAM
Brief Summary:
Gastric myotomy has been performed for several years as a means of addressing chronic stenosis after sleeve gastrectomy and treating gastroparesis The Pylorus Sparing Antral Myotomy PSAM technique has the opposite effect by leaving the pylorus intact and extending the myotomy proximally to the distal gastric body PSAM was initially combined with ESG and shown to delay gastric emptying and provide greater weight loss without impacting tolerability GCSI score or the safety profile of the procedure 2 DDW GEM abstracts PSAM has not been evaluated alone without concomitant ESG Since delayed gastric emptying alone is known to promote weight loss it is thought that PSAM alone without ESG may provide similar efficacy while reducing procedure time and adverse events There have been no clinical studies that investigate the efficacy of PSAM independent of ESG This pilot study aims to address this lack of information by evaluating the safety tolerability and short-term efficacy of PSAM in addition to exploring its impact on gastric physiology This will also provide data that may be used in designing a larger clinical trial
Detailed Description:
Obesity defined as body mass index BMI greater than 30 kgm2 in adults is affecting 30 of the global population and a significant healthcare burden 1 Obesity has increased dramatically over the last few decades with over 650 million adults or 13 of the worlds total adult population diagnosed with the disease in 2016 - a figure that has nearly tripled since 19751 In the US the obesity prevalence for US adults increased from 141 to 267 or an 899 increase between 1993 and 2008123 As a result current and potential interventions and treatment strategies to combat obesity have become more important
The current treatment of obesity involves multiple strategies with combination of non-pharmacologic pharmacologic endoscopic and surgical interventions There are several FDA-approved pharmacotherapies for the treatment of obesity such as orlistat phentermine-topiramate naltrexone-bupropion liraglutide and semaglutide For adults with a body mass index BMI of 40 kgm2 or 35 kgm2 and obesity-related comorbidity bariatric surgery can be offered 4 5 Endoscopic bariatric and metabolic therapies EBMT have emerged as an alternative treatment for patients with obesity with a BMI over 30kgm2 or 27 kgm2 with an obesity-related comorbidity The interest in EBMT is growing given their safety efficacy and non-invasive nature Current FDA-cleared devices that can be used for EBMT include intragastric balloons and suturing devices for endoscopic sleeve gastroplasty ESG Additionally a variety of Endo surgical knifes are approved for tissue dissection such as myotomy
Gastric interventions used to treat obesity work by interfering with gastric accommodation breakdown and mixing of food or gastric emptying Delaying gastric emptying was shown to be a major mechanism of action for both ESG and IGB which is also correlated with weight loss 6
Antral peristalsis constitutes an important mechanism for gastric emptying The antrum also serves as a food sensor which needs to be filled to a certain level before food is pumped into the duodenum 7 Therefore targeting the antrum is a feasible strategy to delay gastric emptying induce satiety and promote weight loss
In fact one of the recently FDA-cleared EBMT devices the Transpyloric Shuttle Baronova MA focuses on inhibiting the antral pump as its primary mechanism of action This device consists of two interconnected large and small bulbs positioned in the antrum and duodenum respectively that cause intermittent obstruction of the pylorus leading to a delay in gastric emptying 10
As such a pylorus sparing antral myotomy PSAM with a submucosal tunneling technique was developed Gastric myotomy has been performed for several years as a means of addressing chronic stenosis after sleeve gastrectomy and treating gastroparesis The PSAM technique has the opposite effect by leaving the pylorus intact and extending the myotomy proximally to the distal gastric body PSAM was initially combined with ESG and shown to delay gastric emptying and provide greater weight loss without impacting tolerability GCSI score or the safety profile of the procedure 2 DDW GEM abstracts PSAM has not been evaluated alone without concomitant ESG Since delayed gastric emptying alone is known to promote weight loss it is thought that PSAM alone without ESG may provide similar efficacy while reducing procedure time and adverse events
Traditional bariatric surgery is very effective at treating obesity however only 1 of eligible patients elect to undergo this treatment option Additionally the majority of patients with obesity do not qualify for bariatric surgery 5 Due to the less invasive nature of PSAM and relative technical simplicity compared to ESG this procedure may provide a more widely available and more acceptable treatment option for some patients
There have been no clinical studies that investigate the efficacy of PSAM independent of ESG This pilot study aims to address this lack of information by evaluating the safety tolerability and short-term efficacy of PSAM in addition to exploring its impact on gastric physiology This will also provide data that may be used in designing a larger clinical trial
The current treatment of obesity involves multiple strategies with combination of non-pharmacologic pharmacologic endoscopic and surgical interventions There are several FDA-approved pharmacotherapies for the treatment of obesity such as orlistat phentermine-topiramate naltrexone-bupropion liraglutide and semaglutide For adults with a body mass index BMI of 40 kgm2 or 35 kgm2 and obesity-related comorbidity bariatric surgery can be offered 4 5 Endoscopic bariatric and metabolic therapies EBMT have emerged as an alternative treatment for patients with obesity with a BMI over 30kgm2 or 27 kgm2 with an obesity-related comorbidity The interest in EBMT is growing given their safety efficacy and non-invasive nature Current FDA-cleared devices that can be used for EBMT include intragastric balloons and suturing devices for endoscopic sleeve gastroplasty ESG Additionally a variety of Endo surgical knifes are approved for tissue dissection such as myotomy
Gastric interventions used to treat obesity work by interfering with gastric accommodation breakdown and mixing of food or gastric emptying Delaying gastric emptying was shown to be a major mechanism of action for both ESG and IGB which is also correlated with weight loss 6
Antral peristalsis constitutes an important mechanism for gastric emptying The antrum also serves as a food sensor which needs to be filled to a certain level before food is pumped into the duodenum 7 Therefore targeting the antrum is a feasible strategy to delay gastric emptying induce satiety and promote weight loss
In fact one of the recently FDA-cleared EBMT devices the Transpyloric Shuttle Baronova MA focuses on inhibiting the antral pump as its primary mechanism of action This device consists of two interconnected large and small bulbs positioned in the antrum and duodenum respectively that cause intermittent obstruction of the pylorus leading to a delay in gastric emptying 10
As such a pylorus sparing antral myotomy PSAM with a submucosal tunneling technique was developed Gastric myotomy has been performed for several years as a means of addressing chronic stenosis after sleeve gastrectomy and treating gastroparesis The PSAM technique has the opposite effect by leaving the pylorus intact and extending the myotomy proximally to the distal gastric body PSAM was initially combined with ESG and shown to delay gastric emptying and provide greater weight loss without impacting tolerability GCSI score or the safety profile of the procedure 2 DDW GEM abstracts PSAM has not been evaluated alone without concomitant ESG Since delayed gastric emptying alone is known to promote weight loss it is thought that PSAM alone without ESG may provide similar efficacy while reducing procedure time and adverse events
Traditional bariatric surgery is very effective at treating obesity however only 1 of eligible patients elect to undergo this treatment option Additionally the majority of patients with obesity do not qualify for bariatric surgery 5 Due to the less invasive nature of PSAM and relative technical simplicity compared to ESG this procedure may provide a more widely available and more acceptable treatment option for some patients
There have been no clinical studies that investigate the efficacy of PSAM independent of ESG This pilot study aims to address this lack of information by evaluating the safety tolerability and short-term efficacy of PSAM in addition to exploring its impact on gastric physiology This will also provide data that may be used in designing a larger clinical trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None