NCT04793347

Brief Summary

the study conducted to assess if there is an effect of Extracorporeal Shock Wave Treatment on anal fissure

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
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

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

March 6, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

March 10, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 11, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2021

Completed
Last Updated

March 11, 2021

Status Verified

March 1, 2021

Enrollment Period

2 months

First QC Date

March 6, 2021

Last Update Submit

March 9, 2021

Conditions

Chronic Anal Fissure

Outcome Measures

Primary Outcomes (1)

  • VAS

    assessment of pain

    up to 3 months

Secondary Outcomes (1)

  • wexener scale

    up to 3 months

Study Arms (1)

shock waves

EXPERIMENTAL

group of patients with anal fissure will be treated with shock waves

Device: shock master (shock waves device)

Interventions

shock master (shock waves device)DEVICE

device produces shock waves

shock waves

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • patient with chronic anal fissure
  • symptomatic for at least 6 months
  • failed conservative measures

You may not qualify if:

  • Pregnant women,
  • cardiac patients,
  • patients with a pacemaker,
  • low molecular heparin or warfarin treatment,
  • neurological disease,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amr

Giza, 12613, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
faculty of physical therapy. Cairo university

Study Record Dates

First Submitted

March 6, 2021

First Posted

March 11, 2021

Study Start

March 10, 2021

Primary Completion

April 30, 2021

Study Completion

May 30, 2021

Last Updated

March 11, 2021

Record last verified: 2021-03

Locations

EG(1)