NCT04349670

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 16, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

May 29, 2020

Status Verified

May 1, 2020

Enrollment Period

4.8 years

First QC Date

April 15, 2020

Last Update Submit

May 27, 2020

Conditions

GastroparesisGastroparesis PostoperativeGastroparesis With Diabetes Mellitus

Keywords

GPOEMgastroparesispyloromyotomy

Outcome Measures

Primary Outcomes (3)

  • Clinical efficacy

    Change in symptomatological scores

    1, 3, 6, 12, 24 months

  • Functional efficacy

    Change of scintigraphy evaluated gastric emptying time

    3, 12, 24 months

  • Complications

    Evaluation of the operative adverse events

    peri-operative time (48 hours)

Secondary Outcomes (1)

  • Correlation of symptoms

    3, 12, 24 months

Interventions

GPOEM - gastric per-oral endoscopic myotomyPROCEDURE

Endoscopic section of the pyloric muscle with submucosal tunnel technique.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients affected with clinical or scintigrafic severe gastroparesis or patients with moderate symptoms/gastric scintigraphic delayed emptying with good response to botulinum.

You may qualify if:

  • 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)

You may not qualify if:

  • Age \< 18 years
  • Inability to understand protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pier Alberto Testoni

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

Stomach DiseasesGastrointestinal DiseasesDigestive System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 15, 2020

First Posted

April 16, 2020

Study Start

June 1, 2020

Primary Completion

April 1, 2025

Study Completion

April 1, 2025

Last Updated

May 29, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)