Biliary ObstructionNCT05634772

Dormia Basket Versus Extraction Ballon in Proximally Migrated Biliary Stents

A study testing dormia basket and Extraction biliary ballon in people with Biliary Obstruction, run by Kafrelsheikh University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Dormia basket versus extraction ballon in proximally migrated biliary stents:A randomized controlled clinical trial Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Biliary Obstruction
What is being tested?: dormia basket and Extraction biliary ballon
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteEgypt
Study dates: 1 Dec 2019to 30 Dec 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adults
both gender
Patients with biliary stenting following ERCP and who had signs of biliary obstruction.

Who cannot join

ERCP without stent insertion.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Mohamed Hussien Ahmed
Kafr ash Shaykh

Other trials in Egypt

About this study

Official title: Dormia Basket Versus Extraction Ballon in Proximally Migrated Biliary Stents:A Randomized Controlled Clinical Trial

Dormia basket versus extraction ballon in proximally migrated biliary stents:A randomized controlled clinical trial

Read the detailed description

Dormia basket versus extraction ballon in proximally migrated biliary stents:A randomized controlled clinical trial The study aims to evaluate the efficacy of dormia basket versus extraction biliary balloon in management of proximal stent migration

Conditions: Biliary Obstruction
Being tested: dormia basket, Extraction biliary ballon

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

dormia basketDevice
Use of dormia basket in management of proximal stent migration
Extraction biliary ballonDevice
Use of extraction biliary balloon in management of proximal stent migration

Study groups in NCT05634772
Study group	Role	What they receive
the efficacy of dormia basket in management of proximal stent migration	Active comparator	Not described Receives: Device: dormia basket
the efficacy of extraction biliary balloon in management of proximal stent migration	Active comparator	Not described Receives: Device: Extraction biliary ballon

What is being measured

The primary outcome is the main question the study is designed to answer.

To compare between dormia basket and extraction ballon in management of proximally migrated biliary stents regarding operative time (min)
Operative time was measured by minutes
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 201930 Dec 2020

First posted2 Dec 2022
Study start1 Dec 2019
Primary completion30 Dec 2020
Study completion30 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Biliary ObstructionStudies of the same condition, open and under way.
More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05634772
Sponsor's protocol ID: Kafrelsheikh U , medicine
Status last verified: Nov 2022
First submitted: 9 Nov 2022
Last updated: 2 Dec 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Ultrasound-Guided Rectus Sheath Block Versus Local Infiltration
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All Biliary Obstruction trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Dormia Basket Versus Extraction Ballon in Proximally Migrated Biliary Stents:A Randomized Controlled Clinical Trial
ClinicalTrials.gov ID: NCT05634772
Acronym / sponsor ID: Kafrelsheikh U , medicine
Conditions: Biliary Obstruction
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Kafrelsheikh UniversityUniversity, hospital or other
Study start: 1 Dec 2019 (actual)
Primary completion: 30 Dec 2020 (actual)
Study completion: 30 Dec 2020 (actual)
First posted: 2 Dec 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Dormia basket versus extraction ballon in proximally migrated biliary stents:A randomized controlled clinical trial

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
the efficacy of dormia basket in management of proximal stent migration	Active comparator	Device: dormia basket
the efficacy of extraction biliary balloon in management of proximal stent migration	Active comparator	Device: Extraction biliary ballon

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Adults
both gender
Patients with biliary stenting following ERCP and who had signs of biliary obstruction.

Key exclusion criteria (1 listed)

ERCP without stent insertion.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
dormia basketUse of dormia basket in management of proximal stent migration	Device	the efficacy of dormia basket in management of proximal stent migration
Extraction biliary ballonUse of extraction biliary balloon in management of proximal stent migration	Device	the efficacy of extraction biliary balloon in management of proximal stent migration

Primary outcome

To compare between dormia basket and extraction ballon in management of proximally migrated biliary stents regarding operative time (min)
Time frame: 4 weeks
Operative time was measured by minutes

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.

Related trials for Biliary Obstruction

Active, not recruitingPhase 2
Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)
Pancreatic Cancer, Hepatocellular Cancer
Not yet recruiting
Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
Postoperative Pain, Acute Pain
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
EUS Procedures Using RIVOS™ EUS Access Device
Pancreatic Fluid Collections, Biliary Obstruction
Recruiting
Ultrasound-Guided Rectus Sheath Block Versus Local Infiltration
Cholelithiases, Cholecystitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing dormia basket and Extraction biliary ballon in people with Biliary Obstruction, run by Kafrelsheikh University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To compare between dormia basket and extraction ballon in management of proximally migrated biliary stents regarding operative time (min) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05634772.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2022.