Magnets and a self-retractable wire for endoscopic septotomies: from concept to first-in-human use.


Journal

Endoscopy
ISSN: 1438-8812
Titre abrégé: Endoscopy
Pays: Germany
ID NLM: 0215166

Informations de publication

Date de publication:
06 2022
Historique:
aheadofprint: 19 07 2021
pubmed: 21 7 2021
medline: 28 5 2022
entrez: 20 7 2021
Statut: ppublish

Résumé

A medical device that allows simple and safe performance of an endoscopic septotomy could have several applications in the gastrointestinal (GI) tract. We have developed such a device by combining two magnets and a self-retractable wire to perform a progressive septotomy by compression of the tissues. We describe here the concept, preclinical studies, and first clinical use of the device for the treatment of symptomatic epiphrenic esophageal diverticulum (EED). The MAGUS (MAgnetic Gastrointestinal Universal Septotome) device was designed based on previous knowledge of compression anastomosis and currently unmet needs. After initial design, the feasibility of the technique was tested on artificial septa in pigs. A clinical trial was then initiated to assess the feasibility and safety of the technique. Animal studies showed that the MAGUS can perform a complete septotomy at various levels of the GI tract. In two patients with a symptomatic EED, uneventful complete septotomy was observed within 28 and 39 days after the endoscopic procedure. This new system provides a way of performing endoluminal septotomy in a single procedure. It appears to be effective and safe for managing symptomatic EED. Further clinical applications where this type of remodeling of the GI tract could be beneficial are under investigation.

Sections du résumé

BACKGROUND
A medical device that allows simple and safe performance of an endoscopic septotomy could have several applications in the gastrointestinal (GI) tract. We have developed such a device by combining two magnets and a self-retractable wire to perform a progressive septotomy by compression of the tissues. We describe here the concept, preclinical studies, and first clinical use of the device for the treatment of symptomatic epiphrenic esophageal diverticulum (EED).
METHODS
The MAGUS (MAgnetic Gastrointestinal Universal Septotome) device was designed based on previous knowledge of compression anastomosis and currently unmet needs. After initial design, the feasibility of the technique was tested on artificial septa in pigs. A clinical trial was then initiated to assess the feasibility and safety of the technique.
RESULTS
Animal studies showed that the MAGUS can perform a complete septotomy at various levels of the GI tract. In two patients with a symptomatic EED, uneventful complete septotomy was observed within 28 and 39 days after the endoscopic procedure.
CONCLUSIONS
This new system provides a way of performing endoluminal septotomy in a single procedure. It appears to be effective and safe for managing symptomatic EED. Further clinical applications where this type of remodeling of the GI tract could be beneficial are under investigation.

Identifiants

pubmed: 34282579
doi: 10.1055/a-1554-0976
pmc: PMC9132732
doi:

Banques de données

ClinicalTrials.gov
['NCT04480216']

Types de publication

Clinical Trial

Langues

eng

Sous-ensembles de citation

IM

Pagination

574-579

Commentaires et corrections

Type : CommentIn

Informations de copyright

The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).

Déclaration de conflit d'intérêts

Daniel Blero, Nicolas Cauche, Cécilia Delattre, Alain Delchambre, Jacques Deviere, Sonia Dugardeyn, François Huberland, and Ricardo Rio Tinto are the inventors of and holders of a patent on the MAGUS device. The remaining authors declare that they have no conflict of interest.

Références

Gut. 2015 Nov;64(11):1678-9
pubmed: 26061594
J Am Coll Surg. 2017 Nov;225(5):676-681.e1
pubmed: 28843832
Gastrointest Endosc. 2010 Sep;72(3):530-5
pubmed: 20656288
J Gastrointest Surg. 2017 Jun;21(6):1067-1075
pubmed: 28108931
Gastroenterology. 1992 Dec;103(6):1732-8
pubmed: 1451966
J Pediatr Surg. 2014 Jul;49(7):1131-7
pubmed: 24952802
Gastrointest Endosc. 2017 Nov;86(5):904-912
pubmed: 28716404
Surg Obes Relat Dis. 2017 Sep;13(9):1501-1505
pubmed: 28552743
Endoscopy. 2019 Apr;51(4):346-349
pubmed: 30453378
Surg Obes Relat Dis. 2007 May-Jun;3(3):408-10
pubmed: 17533103
Endoscopy. 2016;48 Suppl 1:E244-5
pubmed: 27489986

Auteurs

François Huberland (F)

Bio, Electro and Mechanical Systems Department, Université Libre de Bruxelles, Brussels, Belgium.

Ricardo Rio-Tinto (R)

Champalimaud Foundation, Lisbon, Portugal.

Nicolas Cauche (N)

Brussels Medical Device Center, Brussels, Belgium.

Sonia Dugardeyn (S)

Department of Gastroenterology, Hepatopancreatology, and Digestive Oncology, Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium.

Cécilia Delattre (C)

Brussels Medical Device Center, Brussels, Belgium.

Charlotte Sandersen (C)

Department of Clinical Sciences, Faculty of Veterinary Medicine, University of Liège, Liège, Belgium.

Laureen Rocq (L)

Department of Pathology, Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium.

Pauline van Ouytsel (P)

Department of Gastroenterology, Hepatopancreatology, and Digestive Oncology, Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium.

Alain Delchambre (A)

Bio, Electro and Mechanical Systems Department, Université Libre de Bruxelles, Brussels, Belgium.

Jacques Devière (J)

Champalimaud Foundation, Lisbon, Portugal.
Department of Gastroenterology, Hepatopancreatology, and Digestive Oncology, Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium.

Daniel Blero (D)

Department of Gastroenterology, Hepatopancreatology, and Digestive Oncology, Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium.

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female
Humans United States Aged Cross-Sectional Studies Medicare Part C
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH