SCI-Pex, a Multi-center, Prospective, Non-controlled Investigation to Evaluate the Safety and Performance of PexyEazy®, a Device for Treatment of Hemorrhoids

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The SCI-Pex study is a multicenter, prospective, non-controlled investigation on PexyEazy®, a new device for treatment of hemorrhoids based on the mucopexy method. Mucopexy is a well established method where sutures are applied above the hemorrhoids. When knots are tied, the hemorrhoids are lifted inwards to their normal position, which makes them swell down and symptoms disappears. PexyEazy® perform a mukopexy in a semiautomatic, faster and easier way on awake patient in less than 10 minutes. The SCI-Pex study will evaluate the safety and performance of PexyEazy on 35 patients with hemorrhoids grade II and III with a follow-up after 1 week, 3 months and 1 years. Adverse events, pain and other complications will be recorded, quality of life and hemorrhoid symptom questionnaires and clinical examination after 3 months and 1 year will be monitored to evaluate the result after a PexyEazy® procedure.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 84
Healthy Volunteers: f
View:

• Adult

• Hemorrhoidal disease grade II and III

• American Society of Anesthesiologists (ASA) classification I-III.

Locations
Other Locations
Sweden
Frölunda Specialistsjukhus
RECRUITING
Frölunda
Norrtälje Sjukhus
RECRUITING
Norrtälje
Capio kirurgkliniken, Sophiahemmet
NOT_YET_RECRUITING
Stockholm
Contact Information
Primary
Johan Ungerstedt, Dr
johan.ungerstedt@developeration.se
+46709427842
Backup
Ulf Kressner, Dr
ulfkressner@icloud.com
Time Frame
Start Date: 2023-06-15
Estimated Completion Date: 2026-05-30
Participants
Target number of participants: 35
Treatments
Experimental: PexyEazy procedure
PexyEazy procedure on patients with hemorrhoidal disease grade II and III. The study is descriptive and non-comparable to evaluate the safety and performance of PexyEazy.
Related Therapeutic Areas
Sponsors
Leads: Developeration AB

This content was sourced from clinicaltrials.gov