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NCT04349670 Clinical Trial

Safety and Efficacy of GPOEM in the Treatment of Gastroparesis

Gastroparesis Clinical Trial

Official title:
Safety and Efficacy of GPOEM in the Treatment of Gastroparesis

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04349670
Other study ID # GPOEM
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 1, 2020
Est. completion date April 1, 2025

Study information
Verified date May 2020
Source IRCCS San Raffaele
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 40
Est. completion date April 1, 2025
Est. primary completion date April 1, 2025
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• GPOEM - gastric per-oral endoscopic myotomy
Endoscopic section of the pyloric muscle with submucosal tunnel technique.

Locations
Country Name City State
Italy Pier Alberto Testoni Milan

Sponsors (1)
Lead Sponsor Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical efficacy Change in symptomatological scores 1, 3, 6, 12, 24 months
Primary Functional efficacy Change of scintigraphy evaluated gastric emptying time 3, 12, 24 months
Primary Complications Evaluation of the operative adverse events peri-operative time (48 hours)
Secondary Correlation of symptoms Evaluate the correlation between symptoms and gastric emptying 3, 12, 24 months
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