See the published version of this article at BMC Surgery.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research article
Non-active implantable device treating acid reflux with a new dynamic treatment approach: 1-year results
Miloš Bjelović
Corresponding Author
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at BMC Surgery.
BACKGROUND RefluxStop™ is an implantable, non-active, single use device used in the laparoscopic treatment of GERD. RefluxStop™ aims to block the movement of the LES up into the thorax and keep the angle of His in its original, anatomically correct position. This new device restores normal anatomy, leaving the food passageway unaffected.
METHODS In a prospective, single arm, multicentric clinical investigation analyzing safety and effectiveness of the RefluxStop™ device to treat GERD, 50 subjects with chronic GERD were operated using a standardized surgical technique between December 2016 and September 2017. They were followed up for one year (CE-mark investigation 6-months). Primary safety outcome was prevalence of serious adverse events related to the device, and primary effectiveness outcome reduction of GERD symptoms based on GERD-HRQL score. Secondary outcomes were prevalence of adverse events other than serious adverse events, reduction of total acid exposure time in 24-hour pH monitoring, and reduction in average daily PPI usage and subject satisfaction.
RESULTS There were no serious adverse events related to the device. Average GERD-HRQL total score at 1 year improved 86% from baseline (p<0.001). 24-hour pH monitoring compared to baseline showed a mean reduction percentage of overall time with pH<4 from 16.35% to 0.80% at the 6-month visit (p<0.001), with 98% of subjects showing normal 24-hour pH. At 1 year: No new cases of dysphagia were recorded, present in 2 subjects, which existed already at baseline. Regular daily PPI usage occurred in all 50 subjects at baseline. At 1-year follow-up, only 1 subject took regular daily PPIs due to a too low placement of the device thereby prohibiting its function. None or minimal occasional episodes of regurgitation occurred in 97.8% of evaluable subjects. Gas bloating disappeared in 30 subjects and improved in 7 subjects.
CONCLUSION The new principle of RefluxStop™ is safe and effective to treat GERD according to investigation results. At 1-year follow-up, both the GERD-HRQL score and 24-h pH monitoring results indicate success for the new treatment principle. In addition, with the dynamic treatment for acid reflux, which avoids compressing the food passageway, prevalence of dysphagia and gas bloating are significantly reduced.
Keywords
Gastroesophageal reflux disease (GERD), Treatment, Surgery, Reflux-Stop, Dysphagia, pH monitoring, GERD-HRQL, gas bloating
Figure 1
Figure 2
Figure 3
Figure 4
Figure 5
Figure 6
Figure 7
Figure 8
Figure 9
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
Version 4
Posted 10 Jun, 2020
Published
On 20 Jul, 2020
No community comments so far
Submission checks complete
On 05 Jun, 2020
Editorial decision: Accept
On 05 Jun, 2020
No comments provided
Editorial decision: Minor revision
On 01 Jun, 2020
Reviewer #2 agreed
On 29 May, 2020
Review #2 received
Received 29 May, 2020
Editor assigned
On 28 May, 2020
Reviewers invited
Invitations sent on 28 May, 2020
Reviewer #1 agreed
On 28 May, 2020
Review #1 received
Received 28 May, 2020
Submission checks complete
On 27 May, 2020
Editor invited
On 27 May, 2020
No comments provided
Editorial decision: Minor revision
On 22 May, 2020
Reviewer #2 agreed
On 21 May, 2020
Review #1 received
Received 21 May, 2020
Review #2 received
Received 21 May, 2020
Reviewer #1 agreed
On 19 May, 2020
Editor assigned
On 14 May, 2020
Reviewers invited
Invitations sent on 14 May, 2020
Submission checks complete
On 13 May, 2020
Editor invited
On 13 May, 2020
No comments provided
Editorial decision: Minor revision
On 29 Apr, 2020
Review #2 received
Received 28 Apr, 2020
Reviewer #2 agreed
On 26 Apr, 2020
Review #1 received
Received 13 Apr, 2020
Reviewers invited
Invitations sent on 06 Apr, 2020
Reviewer #1 agreed
On 06 Apr, 2020
Editor assigned
On 26 Mar, 2020
Submission checks complete
On 25 Mar, 2020
Editor invited
On 25 Mar, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Gastrointestinal Surgery
Learn more about our company.
This preprint is under consideration at BMC Surgery. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research article
Non-active implantable device treating acid reflux with a new dynamic treatment approach: 1-year results
Miloš Bjelović
Corresponding Author
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
Version 4
Posted 10 Jun, 2020
Published
On 20 Jul, 2020
No community comments so far
Submission checks complete
On 05 Jun, 2020
Editorial decision: Accept
On 05 Jun, 2020
No comments provided
Editorial decision: Minor revision
On 01 Jun, 2020
Reviewer #2 agreed
On 29 May, 2020
Review #2 received
Received 29 May, 2020
Editor assigned
On 28 May, 2020
Reviewers invited
Invitations sent on 28 May, 2020
Reviewer #1 agreed
On 28 May, 2020
Review #1 received
Received 28 May, 2020
Submission checks complete
On 27 May, 2020
Editor invited
On 27 May, 2020
No comments provided
Editorial decision: Minor revision
On 22 May, 2020
Reviewer #2 agreed
On 21 May, 2020
Review #1 received
Received 21 May, 2020
Review #2 received
Received 21 May, 2020
Reviewer #1 agreed
On 19 May, 2020
Editor assigned
On 14 May, 2020
Reviewers invited
Invitations sent on 14 May, 2020
Submission checks complete
On 13 May, 2020
Editor invited
On 13 May, 2020
No comments provided
Editorial decision: Minor revision
On 29 Apr, 2020
Review #2 received
Received 28 Apr, 2020
Reviewer #2 agreed
On 26 Apr, 2020
Review #1 received
Received 13 Apr, 2020
Reviewers invited
Invitations sent on 06 Apr, 2020
Reviewer #1 agreed
On 06 Apr, 2020
Editor assigned
On 26 Mar, 2020
Submission checks complete
On 25 Mar, 2020
Editor invited
On 25 Mar, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Gastrointestinal Surgery
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at BMC Surgery.
BACKGROUND RefluxStop™ is an implantable, non-active, single use device used in the laparoscopic treatment of GERD. RefluxStop™ aims to block the movement of the LES up into the thorax and keep the angle of His in its original, anatomically correct position. This new device restores normal anatomy, leaving the food passageway unaffected.
METHODS In a prospective, single arm, multicentric clinical investigation analyzing safety and effectiveness of the RefluxStop™ device to treat GERD, 50 subjects with chronic GERD were operated using a standardized surgical technique between December 2016 and September 2017. They were followed up for one year (CE-mark investigation 6-months). Primary safety outcome was prevalence of serious adverse events related to the device, and primary effectiveness outcome reduction of GERD symptoms based on GERD-HRQL score. Secondary outcomes were prevalence of adverse events other than serious adverse events, reduction of total acid exposure time in 24-hour pH monitoring, and reduction in average daily PPI usage and subject satisfaction.
RESULTS There were no serious adverse events related to the device. Average GERD-HRQL total score at 1 year improved 86% from baseline (p<0.001). 24-hour pH monitoring compared to baseline showed a mean reduction percentage of overall time with pH<4 from 16.35% to 0.80% at the 6-month visit (p<0.001), with 98% of subjects showing normal 24-hour pH. At 1 year: No new cases of dysphagia were recorded, present in 2 subjects, which existed already at baseline. Regular daily PPI usage occurred in all 50 subjects at baseline. At 1-year follow-up, only 1 subject took regular daily PPIs due to a too low placement of the device thereby prohibiting its function. None or minimal occasional episodes of regurgitation occurred in 97.8% of evaluable subjects. Gas bloating disappeared in 30 subjects and improved in 7 subjects.
CONCLUSION The new principle of RefluxStop™ is safe and effective to treat GERD according to investigation results. At 1-year follow-up, both the GERD-HRQL score and 24-h pH monitoring results indicate success for the new treatment principle. In addition, with the dynamic treatment for acid reflux, which avoids compressing the food passageway, prevalence of dysphagia and gas bloating are significantly reduced.
Figure 1
Figure 2
Figure 3
Figure 4
Figure 5
Figure 6
Figure 7
Figure 8
Figure 9