## Protocol Section
### Identification Module
**NCT ID:** NCT06384079

**Brief Title:** Duration of Ureteral Rest Prior to Ureteral Reconstruction Surgery

**Official Title:** Study to Assess Duration of Ureteral Rest Prior to Ureteral Reconstruction Surgery

#### Organization Study ID Info
**ID:** STU00219828
#### Organization
**Class:** OTHER
**Full Name:** Northwestern University
### Status Module
#### Completion Date
**Date:** 2030-11

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-04-25

**Type:** ACTUAL

**Last Update Submit Date:** 2024-04-22

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-11

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05

**Type:** ESTIMATED

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2024-04-25
**Type:** ACTUAL
**Study First Submit Date:** 2024-02-19
**Study First Submit QC Date:** 2024-04-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Northwestern University

#### Responsible Party

**Investigator Affiliation:** Northwestern University

**Investigator Full Name:** Ziho Lee

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Our objective is to assess the effect of duration of ureteral rest, defined as time from conversion of ureteral stent to percutaneous nephrostomy, on stricture length prior to ureteral reconstruction surgery.

### Conditions Module

**Conditions:**

- Ureteral Stricture

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 25

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Antegrade and retrograde pyelogram will be completed prior to definitive ureteral repair

**Intervention Names:**

- Procedure: Antegrade and retrograde pyelogram

**Label:** Endoscopic Evaluation

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Endoscopic Evaluation

**Description:** Participation in the study will guarantee that participants will receive this procedure.

**Name:** Antegrade and retrograde pyelogram

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Measure:** Ureteral stricture length measured by antegrade or retrograde pyelogram

**Time Frame:** 2 weeks and 6 weeks post procedure

#### Secondary Outcomes

**Measure:** Ureteral Stricture Quality will be graded as either narrowed or obliterated segment.

**Time Frame:** 2 weeks and 6 weeks post procedure

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* \>18 years of age
* Undergoing ureteral reconstruction surgery for ureteral stricture with conversion of an indwelling stent to a percutaneous nephrostomy tube for ureteral rest
* Willing to sign informed consent form
* Able to read and understand informed consent form

Exclusion Criteria:

* \<18 years of age
* Inability to provide informed consent
* Members of vulnerable patient populations

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Subjects over 18 years of age undergoing surgery to fix the ureter.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** emily.ji@nm.org

**Name:** Emily Ji

**Phone:** 312-695-8146

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Chicago

**Contacts:**

***Contact 1:***

- **Email:** emily.ji@nm.org

- **Name:** Emily Ji

- **Phone:** 312-695-8146

- **Role:** CONTACT

***Contact 2:***

- **Name:** Ziho Lee, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Northwestern University

**State:** Illinois

**Status:** RECRUITING

**Zip:** 60611

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Document Section

### Large Document Module

#### Large Docs

- Date: 2023-10-25

- Filename: Prot_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: False

- Label: Study Protocol

- Size: 140931

- Type Abbrev: Prot

- Upload Date: 2024-03-01T13:40

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020763

- Term: Pathological Conditions, Anatomical

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M6475

- Name: Constriction, Pathologic

- Relevance: HIGH

- As Found: Stricture

- ID: M22519

- Name: Pathological Conditions, Anatomical

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003251

- Term: Constriction, Pathologic

### Misc Info Module

- Version Holder: 2024-05-24
