Safety and Efficacy of GPOEM in the Treatment of Gastroparesis

San Donato Group (GSD)

Status: Not yet enrolling

Conditions: Gastroparesis; Gastroparesis With Diabetes Mellitus; Gastroparesis Postoperative

Treatments: Procedure: GPOEM - gastric per-oral endoscopic myotomy

Study type: Observational

Funder types: Other

Identifiers

NCT04349670

GPOEM

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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