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Safety and Efficacy of GPOEM in the Treatment of Gastroparesis

NCT ID: NCT04349670

Last Updated: 2020-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-01

Study Completion Date

2025-04-01

Brief Summary

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The purpose of this study is to assess the clinical efficacy and safety in the treatment of gastroparesis.

Detailed Description

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After being informed about the data collected, all the patients affected with gastroparesis undergoing Gastric Per-Oral Endoscopic Myotomy (GPOEM) will be included in the observational protocol.

Data concerning pre-operative symptoms and results of the imaging studies will be recorded together with operative time and operative complications.

Patients will undergo periodical clinical consults and gastric emptying scintigraphy to assess the improvement in the symptoms and gastric motility.

Conditions

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Gastroparesis Gastroparesis Postoperative Gastroparesis With Diabetes Mellitus

Keywords

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GPOEM gastroparesis pyloromyotomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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GPOEM - gastric per-oral endoscopic myotomy

Endoscopic section of the pyloric muscle with submucosal tunnel technique.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Gastroparesis (GCSI \> 2 OR Gastric emptying half-time \> 180 min OR gastric retention at 120 min \> 60% OR good response to botulinum if former criteria not met)

Exclusion Criteria

* Age \< 18 years
* Inability to understand protocol
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Pier Alberto Testoni

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pier Alberto Testoni

Milan, , Italy

Site Status

Countries

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Italy

Other Identifiers

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GPOEM

Identifier Type: -

Identifier Source: org_study_id