Reduction of gastrojejunal anastomosis with a novel endoscopic clipping device in bariatric patients with gastric bypass for treatment of dumping syndrome - an observation study

Reduction of gastrojejunal anastomosis with a novel endoscopic clipping device in bariatric patients with gastric bypass for treatment of dumping syndrome - an observation study - REDUCE

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00022042

Enrollment

Registered

2020-06-04

Start date

2020-09-21

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

K91.1

Interventions

Group 1: Patients treated with the Bariatric Reduction System

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients treated with Bariatric Reduction System. This means: Proven Dumping syndrome by Sigstad Score >7 and pathologic modified oGTT and refractory to dietary restrictions.

Exclusion criteria

Exclusion criteria: According to contraindications for BARS: - Esophageal or pharyngeal stenosis - no obtainable informed consent - age <18 years - insulin-dependant diabetes mellitus - esophageal varices

Design outcomes

Primary

Measure	Time frame
Technical success (=successful reduction of the anastomotic diameter and/or reduction of the surface area to 20-30%)	—

Secondary

Measure	Time frame
Clinical success: - 50% reduction of sigstad score or below 7 points 4 and 12 weeks after BARS - Change in AUC glucose and insulin in modified oral glucose tolerance test after 4 and 12 weeks - change of heart rate in the modified oral glucose tolerance test after 4 and 12 weeks Quality of life measured with questionnaire (SF-36) before and after 12 weeks Complications Procedure time and intervention time Reduction in gastric emptying via scintigraphy	—

Measure

Time frame

Clinical success: - 50% reduction of sigstad score or below 7 points 4 and 12 weeks after BARS - Change in AUC glucose and insulin in modified oral glucose tolerance test after 4 and 12 weeks - change of heart rate in the modified oral glucose tolerance test after 4 and 12 weeks Quality of life measured with questionnaire (SF-36) before and after 12 weeks Complications Procedure time and intervention time Reduction in gastric emptying via scintigraphy

—

Countries

Germany

Contacts

Public ContactArthur Schmidt

UNIVERSITÄTSKLINIKUM FREIBURG Klinik für Innere Medizin II Gastroenterologie, Hepatologie, Endokrinologie und Infektiologie

arthur.schmidt@uniklinik-freiburg.de0049-761-270-25424

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026